Your authorized representative for medical devices – EU, Switzerland and UK
Are you planning to market your medical device in Europe, Switzerland or the UK? Then you need a local authorized representative to represent you in dealings with the authorities, check your technical documentation and ensure market access. BAYOOCARE supports you as an EU authorized representative (EU-REP), Swiss authorized representative (CH-Rep) and UK Responsible Person (UKRP) – reliably, with regulatory expertise and a clear focus on your success.
Why do you need an Authorized Representative for medical devices?
As a medical device manufacturer not based in the EU, Switzerland or the UK, you are legally obliged to appoint an authorized representative before you are allowed to place your products on the market. This requirement applies to all risk classes according to MDR (EU) 2017/745, IVDR (EU) 2017/746, the Swiss Medical Devices Ordinance (MepV) and the UK Medical Devices Regulations 2002. This regulation serves to protect patients and ensures that medical devices from all over the world meet the same high safety and quality standards as products from locally based manufacturers.
The authorized representative acts as a central interface between you and the responsible authorities, checks the regulatory conformity of your products and takes on defined tasks in the context of market surveillance and vigilance. They are liable for product safety on an equal footing with the manufacturer – a responsibility that requires technical expertise, regulatory experience and robust quality management. Their name and contact details must be indicated on the product label so that users and authorities know immediately who to contact if necessary.
Mandatory designation:
Deadlines, markets and registration
The designation must be made before the first placing on the market and applies to at least one generic product group. Without a mandated authorized representative, registration in the respective systems is not possible – neither in EUDAMED for the EU, nor with Swissmedic for Switzerland or the MHRA for the United Kingdom. It should be noted here: Since the abolition of the Mutual Recognition Agreement between Switzerland and the EU, the CH-Rep is a regulatory requirement for all foreign manufacturers, and the UK Responsible Person is also required for EU manufacturers as soon as their registered office is outside the UK.
BAYOOCARE assumes the role of EU authorized representative for you in accordance with Article 11 MDR and IVDR. With our 8 locations in Germany, we act as your local contact within the European Union. We formally check whether your conformity assessment has been carried out in full, your declaration of conformity meets the regulatory requirements and the technical documentation has been prepared in accordance with your quality management system. This check is not a substantive assessment in the sense of a notified body, but a procedural verification that ensures that all the necessary evidence is available and kept up to date.
We organize the registration of your actor and product data in EUDAMED and obtain the Single Registration Number for you, which you need for legal marketing. We work closely with you to record all information correctly and complete the registration in a timely manner. As soon as authorities request documents, we provide them in the relevant official language and coordinate communication between you and the responsible market surveillance authorities. In the event of incidents, field safety corrective actions or vigilance notifications, we actively work with you to meet regulatory requirements and protect patients in the best possible way.
A central aspect of our work as EU-REP is ongoing document management
We keep your Declaration of Conformity, your Technical Documentation and all relevant certificates for the legally prescribed period of at least ten years (15 years for implants) and ensure that these documents can be made available at any time at the request of the authorities. If it turns out that you are not complying with your regulatory obligations, we are entitled and obliged to terminate the cooperation and inform the competent authority. This escalation option protects both you and us from legal consequences and ensures that only compliant products remain on the market.
Our experts take all relevant interfaces into account when reviewing your documents – from clinical evaluation and risk management to post-market surveillance. We understand the complexity of modern medical devices and know what notified bodies and authorities look for. We pass this experience on to you and help you avoid common stumbling blocks and organize your market approval efficiently.
Since the revised Medical Devices Ordinance (MedDO) and the new Ordinance on In Vitro Diagnostic Medical Devices (IVDD) came into force on May 26, 2021, Switzerland has been considered a third country for regulatory purposes. The previously valid Mutual Recognition Agreement between Switzerland and the EU was not extended to MDR and IVDR, meaning that Swiss manufacturers require an EU-REP and, conversely, foreign manufacturers must mandate a CH-Rep in order to place their products on the market in Switzerland. This requirement applies to all medical devices, regardless of the risk class.
With our location in Basel, we assume the role of the Swiss authorized representative
In this way, we ensure that your products meet the requirements of the MepV (SR 812.213) and IvDV (SR 812.219). We check whether your technical documentation complies with Swiss requirements and whether your conformity assessment has been carried out correctly. We validate the completeness of your Declaration of Conformity and the underlying certificates and register your products with Swissmedic, the Swiss regulatory and supervisory authority for therapeutic products.
A decisive advantage of the Swiss regulation
Your technical documentation can remain in your company in accordance with Article 51 MedDO. You only have to send it to us if Swissmedic requests access to it as part of an inquiry or an audit. This arrangement reduces your administrative workload and allows you to retain control over your sensitive documents, while at the same time we ensure that all documents are available promptly if required.
We also assume the vigilance reporting obligations for you in accordance with Article 66 TPLRO. This means that we report incidents and safety corrective measures in the field to Swissmedic and coordinate communication between you and the authorities. We ensure compliance with all deadlines and reporting obligations and ensure that your products are continuously monitored even after they have been placed on the market. If we receive complaints or indications of safety risks, we will inform you immediately and support you in implementing the necessary corrective measures.
To access the UK market, manufacturers not based in the UK must appoint a UK Responsible Person. The duties of the UKRP are set out in the UK Medical Devices Regulations 2002 (as amended) and largely correspond to the duties of an EU Authorized Representative, but are subject to the UK’s own legal framework. Unlike in the EU, it is not possible in the UK to appoint several UKRPs for different product groups – you may only appoint a single UK Responsible Person for all your products.
Our branch in London
Through our branch in London, we assume the function of UK Responsible Person for the British market. We register your company and your products with the Medicines and Healthcare products Regulatory Agency (MHRA) and maintain these registrations on an ongoing basis. We check whether the required conformity assessment procedures have been carried out, whether your technical documentation is complete and whether the declaration of conformity is available. We take into account both CE-marked products that are currently still allowed to be sold in the UK and UKCA-marked products that will serve the UK market in the long term.
We keep the relevant documents available and provide them to the MHRA on request. We communicate centrally with the authority and coordinate all inquiries, audits and market surveillance measures. Should the MHRA request product samples or require access to any of your products, we will organize the provision and ensure that all requirements are met. In the event of incidents and safety corrective actions in the field, we actively support you, forward complaints and reports from the market to you and, if necessary, escalate to the termination of the mandate if regulatory obligations are not met.
An important difference to the EU-REP is that the UKRP information on the labeling of UKCA-marked products is mandatory, whereas it is not mandatory for CE-marked products. We can advise you individually on which labeling requirements apply to your products and how you can best structure the transition phase between CE and UKCA marking.
Your advantages with BAYOOCARE as an international authorized representative
Through our branch in London, we assume the function of UK Responsible Person for the British market. We register your company and your products with the Medicines and Healthcare products Regulatory Agency (MHRA) and maintain these registrations on an ongoing basis. We check whether the required conformity assessment procedures have been carried out, whether your technical documentation is complete and whether the declaration of conformity is available. We take into account both CE-marked products that are currently still allowed to be sold in the UK and UKCA-marked products that will serve the UK market in the long term.
We keep the relevant documents available and provide them to the MHRA on request. We communicate centrally with the authority and coordinate all inquiries, audits and market surveillance measures. Should the MHRA request product samples or require access to any of your products, we will organize the provision and ensure that all requirements are met. In the event of incidents and safety corrective actions in the field, we actively support you, forward complaints and reports from the market to you and, if necessary, escalate to the termination of the mandate if regulatory obligations are not met.
An important difference to the EU-REP is that the UKRP information on the labeling of UKCA-marked products is mandatory, whereas it is not mandatory for CE-marked products. We can advise you individually on which labeling requirements apply to your products and how you can best structure the transition phase between CE and UKCA marking.
There are many questions about EU-REP, CH-Rep and UKRP. We have answered the most common ones for you – from liability issues and changing the authorized representative to the differences between the three markets. Your question is not listed? Please feel free to contact us.
