![](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE-Produkthaftung-fuer-Medizinprodukte-Sicherheit-Vigilanz-und-regulatorische-Verantwortung.jpg\" "\\"BAYOOCARE")
<\/span><\/div><\/div><\/div>Product liability for medical devices: Safety, Vigilance and Regulatory Responsibility<\/h2><\/div>As an experienced legal manufacturer, BAYOOCARE assumes full manufacturer responsibility for your medical device – from classification and CE marking to post-market surveillance. You concentrate on development and marketing, we take overall regulatory responsibility. <\/p>\n<\/div>
Contact us now<\/span><\/a><\/div><\/div><\/div><\/div><\/div>Product liability for medical devices: Safety, Vigilance and Regulatory Responsibility<\/h1><\/div>As a certified legal manufacturer, we bear full manufacturer responsibility for your medical device. This includes liability in the event of damage. <\/p>\n<\/div>
Contact us now<\/span><\/a><\/div><\/div><\/div><\/span><\/div><\/div><\/div><\/div><\/div>Who is liable for your medical device?<\/h2><\/div>Liability for a medical device lies legally with the manufacturer. More precisely: the legal manufacturer within the meaning of the Medical Device Regulation (MDR, EU Regulation 2017\/745) and the In-Vitro Diagnostic Regulation (IVDR, EU Regulation 2017\/746). This responsibility goes far beyond the formal signing of documents. It means that in the event of an incident, a product recall or a request from the authorities, a specific legal and regulatory person is responsible. <\/p>\n<\/div>
Legal manufacturers as a service: full responsibility, no half measures<\/h2><\/div>When BAYOOCARE acts as your legal manufacturer, we not only assume a formal function. We are responsible for your product vis-\u00e0-vis authorities, notified bodies and the market – in legal, regulatory and technical terms. <\/p>\n
In concrete terms, this means<\/p>\n<\/div><\/div><\/div>
![\"BAYOOCARE](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Vorpruefung-Ihrer-Technischen-Dokumentation.jpg\" "\\"BAYOOCARE")
<\/span><\/div><\/div><\/div>- <\/i><\/span>\n
We are responsible for the product as manufacturer according to MDR\/IVDR.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
We ensure that all requirements for technical documentation, quality management systems and post-market surveillance are met.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
In the event of liability, we are available as the responsible body.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
We coordinate communication with authorities and notified bodies.<\/p>\n<\/div><\/li><\/ul>
You concentrate on development, sales and growth. We have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
Product safety: systematically minimizing liability risks<\/h2><\/div>The most effective means of preventing liability risks is consistent product safety right from the start. BAYOOCARE supports you right from the development phase and ensures that your medical device meets all safety-relevant requirements – before it is launched on the market. <\/p>\n
These include:<\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Risk analysis and management according to ISO 14971<\/h3><\/div><\/div>\nSystematic identification, assessment and minimization of risks over the entire product life cycle – for patients, users and third parties. The basis is the risk management file in accordance with ISO 14971, including risk-benefit assessment in accordance with the MDR. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Technical tests and conformity to standards<\/h3><\/div><\/div>\nDepending on the product category, we support you in implementing relevant standards such as IEC 60601 (electrical safety), IEC 62304 (software life cycle), IEC 62366 (suitability for use) or EMC tests. Only a technically verifiably safe product meets the requirements for CE marking. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Clinical evaluation and PMCF<\/h3><\/div><\/div>\nSafety does not end with market entry. Post-market clinical follow-up (PMCF) provides ongoing clinical evidence and is a central element of MDR-compliant post-market surveillance. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>QMS according to ISO 13485:2016<\/h3><\/div><\/div>\nBAYOOCARE is certified according to ISO 13485:2016 and MDSAP. Our QMS forms the procedural basis for safe products and reliable documentation and also covers approval requirements in Australia, Brazil, Canada, Japan and the USA through MDSAP. <\/p>\n<\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>Vigilance: report incidents before there are problems<\/h2><\/div>An incident involving a medical device is not an exception, but a regulatory defined event for which you must be prepared. The MDR sets out clear deadlines and requirements for when and how incidents must be reported to the competent authorities. <\/p>\n
BAYOOCARE takes over this task completely:<\/p>\n
\n- Evaluation of reportable events according to MDR Article 87 ff.<\/li>\n
- Timely notification to the competent national authorities (e.g. BfArM, Swissmedic, MHRA)<\/li>\n
- Coordination of Field Safety Corrective Actions (FSCA) for safety-critical corrections<\/li>\n
- Creation and publication of Field Safety Notices (FSN)<\/li>\n
- Ongoing trend reporting and periodic safety reports (PSUR\/PMSR)<\/li>\n<\/ul>\n
Especially for companies without their own regulatory affairs department, vigilance is one of the most demanding ongoing tasks in the operation of a medical device. We take this task off your hands – completely and reliably. <\/p>\n<\/div><\/div><\/div>
![](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE-Vigilanz-Zwischenfaelle-melden-bevor-es-Probleme-gibt.jpg\" "\\"BAYOOCARE")
<\/span><\/div><\/div><\/div>Pharmacovigilance: If your product comes into contact with a medicinal product or combination product<\/h3><\/div>If your product is a combination product in which a medical device and a medicinal product are regulated together, additional requirements from the area of pharmacovigilance apply. BAYOOCARE knows the interfaces between MDR and pharmaceutical law and can advise you on the regulatory requirements that apply in your case. <\/p>\n<\/div><\/div><\/div>
Advice on product liability and regulatory strategy<\/h3><\/div>Not every company needs an external legal manufacturer from the outset. Sometimes the first step is to assess your own regulatory setup: What are the specific liability risks? Which measures reduce these risks most effectively? How is your own documentation set up? <\/p>\n
Our regulatory affairs experts analyze your situation and work with you to develop a strategy that fits your company size, product portfolio and resources.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Frequently asked questions<\/h2><\/div><\/div><\/div>The topic of product liability raises many questions. We have answered the most frequently asked ones for you. Your question is not included? Please feel free to contact us. <\/p>\n<\/div><\/div><\/div>
![](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Favicon.png\" "\\"BAYOOCARE")
<\/span><\/div><\/div><\/div>Basics of market authorization<\/h3><\/div><\/i><\/i><\/span>Who is liable for a medical device according to MDR?<\/span><\/a><\/h4><\/div>\nAccording to the Medical Device Regulation (EU Regulation 2017\/745), the legal manufacturer bears full responsibility for a medical device – legally, regulatory and in the event of damage. This is the person or organization that places the product on the market under their name and is responsible for CE marking. Companies that cannot or do not wish to take on this role themselves have the option of commissioning an external legal manufacturer such as BAYOOCARE. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>What does it mean when BAYOOCARE acts as a legal manufacturer?<\/span><\/a><\/h4><\/div>\nBAYOOCARE assumes full regulatory and legal manufacturer responsibility for your medical device – including liability in the event of damage, obligations towards authorities and notified bodies as well as post-market surveillance, vigilance and quality management requirements. You are responsible for development and sales, we have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Which incidents must be reported under MDR and how quickly?<\/span><\/a><\/h4><\/div>\nSerious incidents, i.e. events that have led or could have led to death, serious deterioration in health or a serious risk to patients or users, must be reported. The deadlines are staggered according to severity: immediately in the case of immediate danger to life, in other cases within 15 or 30 days. BAYOOCARE assumes full responsibility for the assessment, documentation and timely notification to the competent authorities. <\/p>\n<\/div><\/div><\/div>
As an experienced legal manufacturer, BAYOOCARE assumes full manufacturer responsibility for your medical device – from classification and CE marking to post-market surveillance. You concentrate on development and marketing, we take overall regulatory responsibility. <\/p>\n<\/div>
Product liability for medical devices: Safety, Vigilance and Regulatory Responsibility<\/h1><\/div>As a certified legal manufacturer, we bear full manufacturer responsibility for your medical device. This includes liability in the event of damage. <\/p>\n<\/div>
Contact us now<\/span><\/a><\/div><\/div><\/div><\/span><\/div><\/div><\/div><\/div><\/div>Who is liable for your medical device?<\/h2><\/div>Liability for a medical device lies legally with the manufacturer. More precisely: the legal manufacturer within the meaning of the Medical Device Regulation (MDR, EU Regulation 2017\/745) and the In-Vitro Diagnostic Regulation (IVDR, EU Regulation 2017\/746). This responsibility goes far beyond the formal signing of documents. It means that in the event of an incident, a product recall or a request from the authorities, a specific legal and regulatory person is responsible. <\/p>\n<\/div>
Legal manufacturers as a service: full responsibility, no half measures<\/h2><\/div>When BAYOOCARE acts as your legal manufacturer, we not only assume a formal function. We are responsible for your product vis-\u00e0-vis authorities, notified bodies and the market – in legal, regulatory and technical terms. <\/p>\n
In concrete terms, this means<\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>- <\/i><\/span>\n
We are responsible for the product as manufacturer according to MDR\/IVDR.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
We ensure that all requirements for technical documentation, quality management systems and post-market surveillance are met.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
In the event of liability, we are available as the responsible body.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
We coordinate communication with authorities and notified bodies.<\/p>\n<\/div><\/li><\/ul>
You concentrate on development, sales and growth. We have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
Product safety: systematically minimizing liability risks<\/h2><\/div>The most effective means of preventing liability risks is consistent product safety right from the start. BAYOOCARE supports you right from the development phase and ensures that your medical device meets all safety-relevant requirements – before it is launched on the market. <\/p>\n
These include:<\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Risk analysis and management according to ISO 14971<\/h3><\/div><\/div>\nSystematic identification, assessment and minimization of risks over the entire product life cycle – for patients, users and third parties. The basis is the risk management file in accordance with ISO 14971, including risk-benefit assessment in accordance with the MDR. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Technical tests and conformity to standards<\/h3><\/div><\/div>\nDepending on the product category, we support you in implementing relevant standards such as IEC 60601 (electrical safety), IEC 62304 (software life cycle), IEC 62366 (suitability for use) or EMC tests. Only a technically verifiably safe product meets the requirements for CE marking. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Clinical evaluation and PMCF<\/h3><\/div><\/div>\nSafety does not end with market entry. Post-market clinical follow-up (PMCF) provides ongoing clinical evidence and is a central element of MDR-compliant post-market surveillance. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>QMS according to ISO 13485:2016<\/h3><\/div><\/div>\nBAYOOCARE is certified according to ISO 13485:2016 and MDSAP. Our QMS forms the procedural basis for safe products and reliable documentation and also covers approval requirements in Australia, Brazil, Canada, Japan and the USA through MDSAP. <\/p>\n<\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>Vigilance: report incidents before there are problems<\/h2><\/div>An incident involving a medical device is not an exception, but a regulatory defined event for which you must be prepared. The MDR sets out clear deadlines and requirements for when and how incidents must be reported to the competent authorities. <\/p>\n
BAYOOCARE takes over this task completely:<\/p>\n
\n- Evaluation of reportable events according to MDR Article 87 ff.<\/li>\n
- Timely notification to the competent national authorities (e.g. BfArM, Swissmedic, MHRA)<\/li>\n
- Coordination of Field Safety Corrective Actions (FSCA) for safety-critical corrections<\/li>\n
- Creation and publication of Field Safety Notices (FSN)<\/li>\n
- Ongoing trend reporting and periodic safety reports (PSUR\/PMSR)<\/li>\n<\/ul>\n
Especially for companies without their own regulatory affairs department, vigilance is one of the most demanding ongoing tasks in the operation of a medical device. We take this task off your hands – completely and reliably. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>Pharmacovigilance: If your product comes into contact with a medicinal product or combination product<\/h3><\/div>If your product is a combination product in which a medical device and a medicinal product are regulated together, additional requirements from the area of pharmacovigilance apply. BAYOOCARE knows the interfaces between MDR and pharmaceutical law and can advise you on the regulatory requirements that apply in your case. <\/p>\n<\/div><\/div><\/div>
Advice on product liability and regulatory strategy<\/h3><\/div>Not every company needs an external legal manufacturer from the outset. Sometimes the first step is to assess your own regulatory setup: What are the specific liability risks? Which measures reduce these risks most effectively? How is your own documentation set up? <\/p>\n
Our regulatory affairs experts analyze your situation and work with you to develop a strategy that fits your company size, product portfolio and resources.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Frequently asked questions<\/h2><\/div><\/div><\/div>The topic of product liability raises many questions. We have answered the most frequently asked ones for you. Your question is not included? Please feel free to contact us. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>Basics of market authorization<\/h3><\/div><\/i><\/i><\/span>Who is liable for a medical device according to MDR?<\/span><\/a><\/h4><\/div>\nAccording to the Medical Device Regulation (EU Regulation 2017\/745), the legal manufacturer bears full responsibility for a medical device – legally, regulatory and in the event of damage. This is the person or organization that places the product on the market under their name and is responsible for CE marking. Companies that cannot or do not wish to take on this role themselves have the option of commissioning an external legal manufacturer such as BAYOOCARE. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>What does it mean when BAYOOCARE acts as a legal manufacturer?<\/span><\/a><\/h4><\/div>\nBAYOOCARE assumes full regulatory and legal manufacturer responsibility for your medical device – including liability in the event of damage, obligations towards authorities and notified bodies as well as post-market surveillance, vigilance and quality management requirements. You are responsible for development and sales, we have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Which incidents must be reported under MDR and how quickly?<\/span><\/a><\/h4><\/div>\nSerious incidents, i.e. events that have led or could have led to death, serious deterioration in health or a serious risk to patients or users, must be reported. The deadlines are staggered according to severity: immediately in the case of immediate danger to life, in other cases within 15 or 30 days. BAYOOCARE assumes full responsibility for the assessment, documentation and timely notification to the competent authorities. <\/p>\n<\/div><\/div><\/div>
As a certified legal manufacturer, we bear full manufacturer responsibility for your medical device. This includes liability in the event of damage. <\/p>\n<\/div>
<\/span><\/div><\/div><\/div><\/div><\/div>Who is liable for your medical device?<\/h2><\/div>Liability for a medical device lies legally with the manufacturer. More precisely: the legal manufacturer within the meaning of the Medical Device Regulation (MDR, EU Regulation 2017\/745) and the In-Vitro Diagnostic Regulation (IVDR, EU Regulation 2017\/746). This responsibility goes far beyond the formal signing of documents. It means that in the event of an incident, a product recall or a request from the authorities, a specific legal and regulatory person is responsible. <\/p>\n<\/div>
Legal manufacturers as a service: full responsibility, no half measures<\/h2><\/div>When BAYOOCARE acts as your legal manufacturer, we not only assume a formal function. We are responsible for your product vis-\u00e0-vis authorities, notified bodies and the market – in legal, regulatory and technical terms. <\/p>\n
In concrete terms, this means<\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>- <\/i><\/span>\n
We are responsible for the product as manufacturer according to MDR\/IVDR.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
We ensure that all requirements for technical documentation, quality management systems and post-market surveillance are met.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
In the event of liability, we are available as the responsible body.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
We coordinate communication with authorities and notified bodies.<\/p>\n<\/div><\/li><\/ul>
You concentrate on development, sales and growth. We have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
Product safety: systematically minimizing liability risks<\/h2><\/div>The most effective means of preventing liability risks is consistent product safety right from the start. BAYOOCARE supports you right from the development phase and ensures that your medical device meets all safety-relevant requirements – before it is launched on the market. <\/p>\n
These include:<\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Risk analysis and management according to ISO 14971<\/h3><\/div><\/div>\nSystematic identification, assessment and minimization of risks over the entire product life cycle – for patients, users and third parties. The basis is the risk management file in accordance with ISO 14971, including risk-benefit assessment in accordance with the MDR. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Technical tests and conformity to standards<\/h3><\/div><\/div>\nDepending on the product category, we support you in implementing relevant standards such as IEC 60601 (electrical safety), IEC 62304 (software life cycle), IEC 62366 (suitability for use) or EMC tests. Only a technically verifiably safe product meets the requirements for CE marking. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Clinical evaluation and PMCF<\/h3><\/div><\/div>\nSafety does not end with market entry. Post-market clinical follow-up (PMCF) provides ongoing clinical evidence and is a central element of MDR-compliant post-market surveillance. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>QMS according to ISO 13485:2016<\/h3><\/div><\/div>\nBAYOOCARE is certified according to ISO 13485:2016 and MDSAP. Our QMS forms the procedural basis for safe products and reliable documentation and also covers approval requirements in Australia, Brazil, Canada, Japan and the USA through MDSAP. <\/p>\n<\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>Vigilance: report incidents before there are problems<\/h2><\/div>An incident involving a medical device is not an exception, but a regulatory defined event for which you must be prepared. The MDR sets out clear deadlines and requirements for when and how incidents must be reported to the competent authorities. <\/p>\n
BAYOOCARE takes over this task completely:<\/p>\n
\n- Evaluation of reportable events according to MDR Article 87 ff.<\/li>\n
- Timely notification to the competent national authorities (e.g. BfArM, Swissmedic, MHRA)<\/li>\n
- Coordination of Field Safety Corrective Actions (FSCA) for safety-critical corrections<\/li>\n
- Creation and publication of Field Safety Notices (FSN)<\/li>\n
- Ongoing trend reporting and periodic safety reports (PSUR\/PMSR)<\/li>\n<\/ul>\n
Especially for companies without their own regulatory affairs department, vigilance is one of the most demanding ongoing tasks in the operation of a medical device. We take this task off your hands – completely and reliably. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>Pharmacovigilance: If your product comes into contact with a medicinal product or combination product<\/h3><\/div>If your product is a combination product in which a medical device and a medicinal product are regulated together, additional requirements from the area of pharmacovigilance apply. BAYOOCARE knows the interfaces between MDR and pharmaceutical law and can advise you on the regulatory requirements that apply in your case. <\/p>\n<\/div><\/div><\/div>
Advice on product liability and regulatory strategy<\/h3><\/div>Not every company needs an external legal manufacturer from the outset. Sometimes the first step is to assess your own regulatory setup: What are the specific liability risks? Which measures reduce these risks most effectively? How is your own documentation set up? <\/p>\n
Our regulatory affairs experts analyze your situation and work with you to develop a strategy that fits your company size, product portfolio and resources.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Frequently asked questions<\/h2><\/div><\/div><\/div>The topic of product liability raises many questions. We have answered the most frequently asked ones for you. Your question is not included? Please feel free to contact us. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>Basics of market authorization<\/h3><\/div><\/i><\/i><\/span>Who is liable for a medical device according to MDR?<\/span><\/a><\/h4><\/div>\nAccording to the Medical Device Regulation (EU Regulation 2017\/745), the legal manufacturer bears full responsibility for a medical device – legally, regulatory and in the event of damage. This is the person or organization that places the product on the market under their name and is responsible for CE marking. Companies that cannot or do not wish to take on this role themselves have the option of commissioning an external legal manufacturer such as BAYOOCARE. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>What does it mean when BAYOOCARE acts as a legal manufacturer?<\/span><\/a><\/h4><\/div>\nBAYOOCARE assumes full regulatory and legal manufacturer responsibility for your medical device – including liability in the event of damage, obligations towards authorities and notified bodies as well as post-market surveillance, vigilance and quality management requirements. You are responsible for development and sales, we have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Which incidents must be reported under MDR and how quickly?<\/span><\/a><\/h4><\/div>\nSerious incidents, i.e. events that have led or could have led to death, serious deterioration in health or a serious risk to patients or users, must be reported. The deadlines are staggered according to severity: immediately in the case of immediate danger to life, in other cases within 15 or 30 days. BAYOOCARE assumes full responsibility for the assessment, documentation and timely notification to the competent authorities. <\/p>\n<\/div><\/div><\/div>
Liability for a medical device lies legally with the manufacturer. More precisely: the legal manufacturer within the meaning of the Medical Device Regulation (MDR, EU Regulation 2017\/745) and the In-Vitro Diagnostic Regulation (IVDR, EU Regulation 2017\/746). This responsibility goes far beyond the formal signing of documents. It means that in the event of an incident, a product recall or a request from the authorities, a specific legal and regulatory person is responsible. <\/p>\n<\/div>
Legal manufacturers as a service: full responsibility, no half measures<\/h2><\/div>When BAYOOCARE acts as your legal manufacturer, we not only assume a formal function. We are responsible for your product vis-\u00e0-vis authorities, notified bodies and the market – in legal, regulatory and technical terms. <\/p>\n
In concrete terms, this means<\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>- <\/i><\/span>\n
We are responsible for the product as manufacturer according to MDR\/IVDR.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
We ensure that all requirements for technical documentation, quality management systems and post-market surveillance are met.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
In the event of liability, we are available as the responsible body.<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
We coordinate communication with authorities and notified bodies.<\/p>\n<\/div><\/li><\/ul>
You concentrate on development, sales and growth. We have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
Product safety: systematically minimizing liability risks<\/h2><\/div>The most effective means of preventing liability risks is consistent product safety right from the start. BAYOOCARE supports you right from the development phase and ensures that your medical device meets all safety-relevant requirements – before it is launched on the market. <\/p>\n
These include:<\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Risk analysis and management according to ISO 14971<\/h3><\/div><\/div>\nSystematic identification, assessment and minimization of risks over the entire product life cycle – for patients, users and third parties. The basis is the risk management file in accordance with ISO 14971, including risk-benefit assessment in accordance with the MDR. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Technical tests and conformity to standards<\/h3><\/div><\/div>\nDepending on the product category, we support you in implementing relevant standards such as IEC 60601 (electrical safety), IEC 62304 (software life cycle), IEC 62366 (suitability for use) or EMC tests. Only a technically verifiably safe product meets the requirements for CE marking. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Clinical evaluation and PMCF<\/h3><\/div><\/div>\nSafety does not end with market entry. Post-market clinical follow-up (PMCF) provides ongoing clinical evidence and is a central element of MDR-compliant post-market surveillance. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>QMS according to ISO 13485:2016<\/h3><\/div><\/div>\nBAYOOCARE is certified according to ISO 13485:2016 and MDSAP. Our QMS forms the procedural basis for safe products and reliable documentation and also covers approval requirements in Australia, Brazil, Canada, Japan and the USA through MDSAP. <\/p>\n<\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>Vigilance: report incidents before there are problems<\/h2><\/div>An incident involving a medical device is not an exception, but a regulatory defined event for which you must be prepared. The MDR sets out clear deadlines and requirements for when and how incidents must be reported to the competent authorities. <\/p>\n
BAYOOCARE takes over this task completely:<\/p>\n
\n- Evaluation of reportable events according to MDR Article 87 ff.<\/li>\n
- Timely notification to the competent national authorities (e.g. BfArM, Swissmedic, MHRA)<\/li>\n
- Coordination of Field Safety Corrective Actions (FSCA) for safety-critical corrections<\/li>\n
- Creation and publication of Field Safety Notices (FSN)<\/li>\n
- Ongoing trend reporting and periodic safety reports (PSUR\/PMSR)<\/li>\n<\/ul>\n
Especially for companies without their own regulatory affairs department, vigilance is one of the most demanding ongoing tasks in the operation of a medical device. We take this task off your hands – completely and reliably. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>Pharmacovigilance: If your product comes into contact with a medicinal product or combination product<\/h3><\/div>If your product is a combination product in which a medical device and a medicinal product are regulated together, additional requirements from the area of pharmacovigilance apply. BAYOOCARE knows the interfaces between MDR and pharmaceutical law and can advise you on the regulatory requirements that apply in your case. <\/p>\n<\/div><\/div><\/div>
Advice on product liability and regulatory strategy<\/h3><\/div>Not every company needs an external legal manufacturer from the outset. Sometimes the first step is to assess your own regulatory setup: What are the specific liability risks? Which measures reduce these risks most effectively? How is your own documentation set up? <\/p>\n
Our regulatory affairs experts analyze your situation and work with you to develop a strategy that fits your company size, product portfolio and resources.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Frequently asked questions<\/h2><\/div><\/div><\/div>The topic of product liability raises many questions. We have answered the most frequently asked ones for you. Your question is not included? Please feel free to contact us. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>Basics of market authorization<\/h3><\/div><\/i><\/i><\/span>Who is liable for a medical device according to MDR?<\/span><\/a><\/h4><\/div>\nAccording to the Medical Device Regulation (EU Regulation 2017\/745), the legal manufacturer bears full responsibility for a medical device – legally, regulatory and in the event of damage. This is the person or organization that places the product on the market under their name and is responsible for CE marking. Companies that cannot or do not wish to take on this role themselves have the option of commissioning an external legal manufacturer such as BAYOOCARE. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>What does it mean when BAYOOCARE acts as a legal manufacturer?<\/span><\/a><\/h4><\/div>\nBAYOOCARE assumes full regulatory and legal manufacturer responsibility for your medical device – including liability in the event of damage, obligations towards authorities and notified bodies as well as post-market surveillance, vigilance and quality management requirements. You are responsible for development and sales, we have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Which incidents must be reported under MDR and how quickly?<\/span><\/a><\/h4><\/div>\nSerious incidents, i.e. events that have led or could have led to death, serious deterioration in health or a serious risk to patients or users, must be reported. The deadlines are staggered according to severity: immediately in the case of immediate danger to life, in other cases within 15 or 30 days. BAYOOCARE assumes full responsibility for the assessment, documentation and timely notification to the competent authorities. <\/p>\n<\/div><\/div><\/div>
When BAYOOCARE acts as your legal manufacturer, we not only assume a formal function. We are responsible for your product vis-\u00e0-vis authorities, notified bodies and the market – in legal, regulatory and technical terms. <\/p>\n
In concrete terms, this means<\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>- <\/i><\/span>\n
We are responsible for the product as manufacturer according to MDR\/IVDR.<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nWe ensure that all requirements for technical documentation, quality management systems and post-market surveillance are met.<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nIn the event of liability, we are available as the responsible body.<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nWe coordinate communication with authorities and notified bodies.<\/p>\n<\/div><\/li><\/ul>
You concentrate on development, sales and growth. We have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
Product safety: systematically minimizing liability risks<\/h2><\/div>
The most effective means of preventing liability risks is consistent product safety right from the start. BAYOOCARE supports you right from the development phase and ensures that your medical device meets all safety-relevant requirements – before it is launched on the market. <\/p>\n
These include:<\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Risk analysis and management according to ISO 14971<\/h3><\/div>
<\/div>\nSystematic identification, assessment and minimization of risks over the entire product life cycle – for patients, users and third parties. The basis is the risk management file in accordance with ISO 14971, including risk-benefit assessment in accordance with the MDR. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Technical tests and conformity to standards<\/h3><\/div>
<\/div>\nDepending on the product category, we support you in implementing relevant standards such as IEC 60601 (electrical safety), IEC 62304 (software life cycle), IEC 62366 (suitability for use) or EMC tests. Only a technically verifiably safe product meets the requirements for CE marking. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>Clinical evaluation and PMCF<\/h3><\/div>
<\/div>\nSafety does not end with market entry. Post-market clinical follow-up (PMCF) provides ongoing clinical evidence and is a central element of MDR-compliant post-market surveillance. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>QMS according to ISO 13485:2016<\/h3><\/div>
<\/div>\nBAYOOCARE is certified according to ISO 13485:2016 and MDSAP. Our QMS forms the procedural basis for safe products and reliable documentation and also covers approval requirements in Australia, Brazil, Canada, Japan and the USA through MDSAP. <\/p>\n<\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>Vigilance: report incidents before there are problems<\/h2><\/div>
An incident involving a medical device is not an exception, but a regulatory defined event for which you must be prepared. The MDR sets out clear deadlines and requirements for when and how incidents must be reported to the competent authorities. <\/p>\n
BAYOOCARE takes over this task completely:<\/p>\n
- \n
- Evaluation of reportable events according to MDR Article 87 ff.<\/li>\n
- Timely notification to the competent national authorities (e.g. BfArM, Swissmedic, MHRA)<\/li>\n
- Coordination of Field Safety Corrective Actions (FSCA) for safety-critical corrections<\/li>\n
- Creation and publication of Field Safety Notices (FSN)<\/li>\n
- Ongoing trend reporting and periodic safety reports (PSUR\/PMSR)<\/li>\n<\/ul>\n
Especially for companies without their own regulatory affairs department, vigilance is one of the most demanding ongoing tasks in the operation of a medical device. We take this task off your hands – completely and reliably. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>Pharmacovigilance: If your product comes into contact with a medicinal product or combination product<\/h3><\/div>
If your product is a combination product in which a medical device and a medicinal product are regulated together, additional requirements from the area of pharmacovigilance apply. BAYOOCARE knows the interfaces between MDR and pharmaceutical law and can advise you on the regulatory requirements that apply in your case. <\/p>\n<\/div><\/div><\/div>
Advice on product liability and regulatory strategy<\/h3><\/div>
Not every company needs an external legal manufacturer from the outset. Sometimes the first step is to assess your own regulatory setup: What are the specific liability risks? Which measures reduce these risks most effectively? How is your own documentation set up? <\/p>\n
Our regulatory affairs experts analyze your situation and work with you to develop a strategy that fits your company size, product portfolio and resources.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
Contact us<\/h3><\/div>
Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Frequently asked questions<\/h2><\/div><\/div><\/div>
The topic of product liability raises many questions. We have answered the most frequently asked ones for you. Your question is not included? Please feel free to contact us. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>Basics of market authorization<\/h3><\/div>
<\/i><\/i><\/span>Who is liable for a medical device according to MDR?<\/span><\/a><\/h4><\/div>
\nAccording to the Medical Device Regulation (EU Regulation 2017\/745), the legal manufacturer bears full responsibility for a medical device – legally, regulatory and in the event of damage. This is the person or organization that places the product on the market under their name and is responsible for CE marking. Companies that cannot or do not wish to take on this role themselves have the option of commissioning an external legal manufacturer such as BAYOOCARE. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>What does it mean when BAYOOCARE acts as a legal manufacturer?<\/span><\/a><\/h4><\/div>
\nBAYOOCARE assumes full regulatory and legal manufacturer responsibility for your medical device – including liability in the event of damage, obligations towards authorities and notified bodies as well as post-market surveillance, vigilance and quality management requirements. You are responsible for development and sales, we have overall regulatory responsibility. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Which incidents must be reported under MDR and how quickly?<\/span><\/a><\/h4><\/div>
\nSerious incidents, i.e. events that have led or could have led to death, serious deterioration in health or a serious risk to patients or users, must be reported. The deadlines are staggered according to severity: immediately in the case of immediate danger to life, in other cases within 15 or 30 days. BAYOOCARE assumes full responsibility for the assessment, documentation and timely notification to the competent authorities. <\/p>\n<\/div><\/div><\/div>
- <\/i><\/span>
![\"BAYOOCARE](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Alfred-Koch-CEO-PRRC.png\" "\\"BAYOOCARE")
<\/span><\/div><\/div><\/div>