Are you Considering Selling your Medical Devices & IVD Devices in the European Union?
Please remember that it is mandatory for medical device manufacturers located outside the EU to appoint an EU Authorised Representative. The EU REP plays a pivotal role in ensuring the compliance of devices produced by manufacturers who are located outside the EU and serves as their contact person established in the EU.
Therefore, the EU REP plays a critically important regulatory role.
It’s Essential to Make the Right Choice!
There is a little-known fact that EU REPs are now being supervised and audited by EU competent authorities, which makes the choice of appointing an EU REP significantly more challenging and important for the manufacturer.
In the Netherlands for example, The Dutch Health and Youth Care Inspectorate (IGJ) recently found a number of EU REPs to be deficient and non-compliant in a number of ways:
- Using virtual offices/PO Box addresses with no employees at the EU REP address.
- PRRC without the necessary experience or qualifications.
- PRRC located outside the EU.
- Non-complaint with Article 11 of the MDR/VDR.
- Non-complaint with MDCG 2022-16
It is entirely possible that these non-compliances could lead to a major non-conformity for medical device and IVD manufacturers, requiring them to find and appoint a new EU REP.
Our Advice to Manufacturers
The simple answer is to check their credentials:
- Are they a member of the European Association of Authorised Representatives (EAAR)? This alone should give some confidence.
- Is their mandate detailed? Does it cover the requirements of the MDR/IVDR?
- Do they meet the requirements of MDCG 2022-16?
- Do they have an ISO13485:2016 quality management system? This is not essential, but it should give any manufacturer confidence.
- Do they have a physical address, with employees present?
- Do they have a PRRC within their own organisation that meets the requirements of Article 15?
- A responsible and regulatory compliant EU REP will verify that a manufacturers Technical Documentation and EU Declaration of Conformity has been drawn up, and, where applicable a valid CE certificate exists. If they don’t ask for it, consider it a RED FLAG!
Non-EU manufacturers should take the appointment of an EU Authorised Representative seriously, after all an EU REP is effectively a ‘gatekeeper’ to the EU market and contributes to ensure healthcare and patients in the EU can rely on devices being placed on the EU market and are complaint with applicable EU legislation.
Keep in mind that not all EU REPs are the same, service levels will vary as will prices, and with the non-compliances noted above, you can begin to understand why this is the case.
How Can Advena Help?
Obviously, we would encourage non-EU manufacturer to reach out to Advena and to engage with us, you can email us as at info@advena.mt or visit our website: www.advena.mt but the choice is yours, there are many good and reliable EU REPs out there, unfortunately there are many more that are not.
Choose wisely and check credentials!
