MedTech Europe is very concerned about the implications of a divergence in the regulatory framework for medical devices and in vitro diagnostics arising from Brexit.
The devicemaker group released a position paper suggesting possible ways to mitigate risks during the negotiation period between the UK and the European Union. The paper lists three challenges that could affect the supply of medical devices in both markets:
As the EU implements its new medical device and IVD regulations, the association is urging the UK to remain aligned with the EU27 regulatory system, saying that any divergence of regulatory systems, even in secondary legislation, would impact manufacturers and suppliers by adding costs and complexities in bringing products to market.
Notified bodies remain a particular area of concern as capacity is limited due to the greater workload associated with the new regulations.
“UK notified bodies are used for large amounts of CE marking activity and the risk to lose this capacity due to Brexit needs to be mitigated,” said MedTech Europe CEO Serge Bernasconi.
Certificates Could Pose a Problem
The association suggested that certificates of conformity assessment to current regulations that were issued by UK notified bodies might be void earlier than in other EU27 countries, which would result in manufacturers facing delays in obtaining market authorization.
To mitigate this risk, the paper suggests recognizing existing valid CE Marking certificates issued by UK notified bodies until their expiration date. UK notified bodies could also remain within the existing EU network and continue to be designated to assess devices for the EU27 and UK markets, similar to the arrangement for Swiss notified bodies.
Other considerations outlined in the paper include authorized representatives that would no longer be able to operate from the UK, and manufacturers based only in the UK could lose access to the European market. Solutions could include mutual recognition agreements and custom arrangements to allow for products to cross borders without lengthy delays.
In addition, tariffs should not be placed on medical devices when they are being repaired in the UK and sent back to the EU and vice versa, MedTech Europe said, and the movement of dual-use goods between the UK and the EU27 countries should be permitted in new customs arrangements.
UK competent authorities could also lose access to various EU networks, such as the laboratory network established under the new EU directive as well as the Eudamed database. MedTech Europe suggests devising a framework for collaboration during the transition and post-Brexit.
Similar agreements should also be made for warehousing and manufacturing raw materials, unfinished products and animal material used for medical devices.
The majority of device companies in the UK and the EU are small to medium enterprises, and they may stagnate due to uncertainty surrounding regulations in the UK post Brexit, stakeholders suggested in earlier comments (IDDM, Sept. 25).
Read the MedTech Europe position paper here: www.fdanews.com/11-16-17-MTEBrexitpositionpaper.pdf.