Product liability for medical devices: Safety, Vigilance and Regulatory Responsibility
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.
Who is liable for your medical device?
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.
Legal manufacturers as a service: full responsibility, no half measures
When BAYOOCARE acts as your legal manufacturer, we not only assume a formal function. We are responsible for your product vis-à-vis authorities, notified bodies and the market – in legal, regulatory and technical terms.
In concrete terms, this means
You concentrate on development, sales and growth. We have overall regulatory responsibility.
Product safety: systematically minimizing liability risks
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.
These include:
Vigilance: report incidents before there are problems
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.
BAYOOCARE takes over this task completely:
- Evaluation of reportable events according to MDR Article 87 ff.
- Timely notification to the competent national authorities (e.g. BfArM, Swissmedic, MHRA)
- Coordination of Field Safety Corrective Actions (FSCA) for safety-critical corrections
- Creation and publication of Field Safety Notices (FSN)
- Ongoing trend reporting and periodic safety reports (PSUR/PMSR)
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.
Pharmacovigilance: If your product comes into contact with a medicinal product or combination product
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.
Advice on product liability and regulatory strategy
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?
Our regulatory affairs experts analyze your situation and work with you to develop a strategy that fits your company size, product portfolio and resources.
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.
