Regulatory Expert Gert Bos Shares Insights on Europe’s Notified Bodies

Devicemakers are closely watching the EMA and the U.K.’s Medicines and Healthcare products Regulatory Agency for assurances on how conformity assessments will unfold under the new EU regulations. With fewer notified bodies in the EU, and the added complication of Brexit, the next steps remain uncertain. Qserve Group Executive Director Gert Bos — an auditor and former head of a notified body — spoke with IDDM on the changing environment and how devicemakers can plan for upcoming conformity assessments.

Question: How is the U.K. planning on handling notified bodies with respect to the U.K.’s exit from the European Union?

Answer: There are several contributors to this debate, and multiple strategies are being considered. Besides the possibility that the Brexit process will be reversed and all things stay as normal, there are a number of possible scenarios to consider, such as:

• Brexit combined with a direct or indirect mutual recognition agreement (MRA) via the European Free Trade agreement: the U.K. would continue to use the EU CE-marking process and U.K. notified bodies would remain in place;
• Brexit, followed by direct or indirect MRA: As there would be a gap in U.K. continuing to use the EU CE-marking process, U.K. notified bodies might temporarily be unable to perform their tasks; debate would be needed on whether notification can be re-instated when an MRA is signed, or if new designation is to be in place;
• Brexit without MRA: U.K. notified bodies would no longer be operational for EU CE marking, but might get a role in market approval and oversight for a new U.K. medical device legislative framework.

The MHRA publicly indicated it is planning for a smooth process in which both MHRA and U.K. notified bodies may continue their current role. Meanwhile, U.K. notified bodies are indicating they are preparing for alternative solutions to continue serving their CE-certificate holders, such as by applying as a notified body in another country, or by extending the scope of their EU-based notified bodies.

When a new notified body is in place, transfer of certificates might be proposed to the certification holders. As certificate holders would already be confronted with labeling changes due to the notified body number changing, some are indicating to presume this would be an administrative transfer, rather than a transfer with acceptance review. As current interpretation on MDD compliance requirements is rapidly evolving, transfer reviews might find a compliance backlog, and hence transfers might become complex. A pragmatic approach will be required to ensure a smooth process.

Q: How should devicemakers wanting to market their products in the U.K. approach notified bodies?

A: The key is good communication with a U.K. notified body if you are working with them. Get in touch, get to understand their strategy and expected timelines, discuss transfer processes where needed, and apply so you’re not last in line! Also, remember that U.K. notified bodies did not push for such an agenda; this was a decision from the voters in U.K..

Q: How do you see the role of EU notified bodies changing?

A: Key elements in the new role include focus on full compliance instead of looking for sufficient evidence on conformity. Secondly, in the transfer to the EU Medical Device Regulation (MDR) and Invitro Diagnostic Device Regulation (IVDR), there will not be any harmonized standard in the early days, so the conformity assessment cannot use the presumption of conformity via use of standards as is widely practiced.

Hence, the focus is on demonstrating full compliance to the legal requirements directly. Enhanced supervision on notified bodies will continue, but most notably several consultation and scrutiny processes have been added, and notified bodies will find it harder to disagree with the various agencies recommendations. The essence of the notified body work will not change, but the reality might well find more black and white strict interpretations.

Q: How should devicemakers view the looming exit of the U.K.? Should they be concerned?

A: I’d rather use the word vigilant. With that I mean that manufacturers should proactively approach their notified bodies to communicate details of the transition planning in various outcomes of the Brexit negotiations. Details from such communication can then feed into their corporate risk management assessments. Most difficult in this regard is the timeline associated with the Brexit process. This ends around 14 months before the end of the three-year MDR transition, just at the time when first designations under the MDR are expected.

This means that transferring to a new notified body, which might well be the sister organization of the current notified body, most likely will need to happen before the MDR designation is in place, so under MDD/AIMD or IVD designation, but in a time where MDR implementation is already partially ongoing. It will be essential to get MDD/AIMD/IVD certification in place early, as they will form the basis for the soft-transition market continuation. At such a time, labeling, marketing, declaration of conformity, free sales certificate, global registrations based on CE marking, etc., will need to be updated, and they will again need to be updated once MDR certification is in place.

Besides the uncertainty over which process needs to be followed, depending on the course of the Brexit negotiations, more resources will be required for all the double administrative handling.