Want to market your Medical or IV Devices in the EU? After the MDR 2017 (145 & 146), you are required to appoint an EU Authorized Representative to represent your company’s best interests to the EU authorities. This page will help you understand the crucial roles and responsibilities they play in ensuring your success in the Union.
European Union Authorized Representative (EU Rep) is a legal entity based within the EU(or registered in the EU).
EU Rep can be a person or a company (like Cert3global) who acts on behalf of a non-EU manufacturer as a ‘regulatory representative’ and a crucial point of contact between the non-EU-based Manufacturer and European Authorities.
They act in agreement with the manufacturer and have access to full technical documentation and are kept informed of any changes in Legal regulations.
Roles and Responsibilities of EU Authorized Person
Representational & Formal
Assist with device registration and other formalities, when needed
Be identified on the device labeling, packaging, and Instructions For Use as the official Authorized Representative.
Assist with the incident and Field Safety Corrective Action (FSCA)reporting in coordination with Non-EU Manufacturers and Distributors.
Legal Responsibility
In case of any defectiveness in the medical or IVD device, The EU Rep will be held legally liable along with the manufacturer.
Hence it is crucial to appoint a competent entity possessing the required skillset & experience to monitor the whole compliance process with care.
Competent Authorities can inspect them to determine their relevant understanding and access to Technical Documentation, and have the right processes in place to meet the obligations.
Documentation
A European Auth Rep:
keeps a separate copy of Verified (as per regulations) Technical documentation or CE Declaration of Conformity available when required by the Authority. (10 years for non-implantable devices and 15 years for implantable devices.)
executes proper agreements with Non-EU Manufacturer(s) containing the roles & responsibilities of both parties throughout the product lifecycle.
ensures that the manufacturer has fulfilled EUDAMED Registration Obligations and also applies, reviews, and verifies their EUDAMED SRN (Single Registration Number)
Why Appointing an EU Authorized Rep is Required for Medical Devices?
Non-EU Manufacturers can only market their medical or In Vitro Diagnostic medical devices after appointing an EU Rep as per MDR (Medical Device Regulatory) 2017/745 & 746. They assist in the device registration process and keep compliance documents with them for 10 (or more ) years. Verify EU Declaration of Conformity and technical files.The EAR must receive an agreement with the manufacturer and act as per that.
Can You Appoint Your Distributor as an Authorized Person?
One of the responsibilities of the EU Authorized Representative is to protect the interests of the manufacturer they represent. Hence it is important to keep this in consideration when choosing one for your respective organization. A distributor may not be able to make independent decisions in your organization’s Interests every time and here are some arguments to support this:
Heavy Reliance on distributors as your sales will depend on their activities & commitment. Also, other important aspects like promotions, pricing, or customer interactions will be under their control.
The Market Access of the manufacturer will be limited to the distributor’s network and they will miss out on other opportunities.
If the distributor also sells competing products, then making sure that they will protect the interests of a particular manufacturer is difficult.
Financially, if the distributor takes a significant cut from the sales, then the manufacturer will miss out on their margins, especially if they are a small company.
Hence, keeping the above points in consideration, it is in the manufacturer’s best long-term interest to hire independent Agency Consultants who are not in the business of distributing medical devices. Cert3global is a team of one such independent Agency that acts in the best interests of non-EU manufacturers. We have the expertise and experience to help many in their complete compliance process.
Why Choose Cert3global as Your European Authorized Representative?
Cert3gobal offers Exhaustive support to non-European manufacturers who wish to enter and upkeep their presence in the EU Market with their Medical or IVD (In Vitro Diagnostic) Device.
Our Experienced and Expert regulatory consultants will review your Technical documents, register your device, and represent your best interests to the competent authorities.
We have proper processes in place utilizing technology in all steps of the process, right from the digital safety of documents and updating your team regarding the latest regulatory and market updates.
We offer specifically medical device regulatory consulting services (unlike Distributors and legal Firms) to many manufacturers worldwide (EU, USA & UK), hence our diverse experience will help you get the best quality service out of your money.
Hiring us as your EU Authorized Representative will be in the best interest of your organization’s long-term market success in the Union. Send us a query to know more. Let’s collaborate to start your market journey in the world’s one of the most valuable medical device markets which generates $122 bn (2020) each year as revenue and accounts for 30% of the market worldwide.
