How does a hard exit affect MHRA?

Brexit: effects on the medical device industry

Effects of a (“no-deal”) Brexit on the medical device industry

Consequences of Brexit for UK based companies

Medical device manufacturers based outside the EU who want to market their products within the EU need a European Authorized Representative (EC REP) based in the Union who acts as a contact person for the national supervisory authorities.

Therefore, medical device manufacturers based in the United Kingdom who wish to continue to market their products in the Union will also need an authorized representative within the EU-27 from the day they leave the EU (probably March 29, 2019).

Consequences of Brexit for companies based outside the EU and with a British agent

Medical device manufacturers who have previously worked with a British EC REP will have to look for a new representative outside the UK in one of the EU-27 countries from Brexit. Representation within the EU by an authorized representative in the United Kingdom is no longer possible after leaving the Union.

Consequences of Brexit for (not yet) CE marked products on the EU-27 market and on the UK market

The Medicines and Healthcare Products Regulatory Agency (= MHRA) expects in the course of Brexit that the EU-27 will no longer accept certificates issued by British notified bodies after March 29, 2019. This means that manufacturers who want to place products on the market in the EU-27 must apply for recertification by a notified body of the EU-27.

Conversely, for the UK market, the MHRA intends to give the existing UK Notified Bodies ongoing legal status in order to recognize the validity of certificates that they issued before March 29, 2019. This means that certificates for products placed on the UK market and issued by the British Notified Bodies will remain valid even after Great Britain has left.

With regard to new - not yet marketed - products that are to be marketed in Great Britain in the future, manufacturers are initially only advised to cooperate with a notified body within an EU-27 country.

If a product bears the CE mark in accordance with EU directives or EU regulations, it may (continue to) be sold on the UK and EU-27 markets.

Registration of medical devices in the UK after Brexit

The so-called Medical Device Regulation 2002 (MDR UK 2002) implements the directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC into national British law. According to the draft MDR UK 2019, changes will be made to MDR UK 2002 in particular, which are necessary for the UK to leave the EU.

All products placed on the UK market must be registered with the MHRA from 03/29/2019. Registration will only take place if proof of UK “registered office” is provided. Depending on the risk class of the product, there are certain transition periods for these registration obligations.

The UK will continue to accept existing clinical trial approvals so there will be no need to re-submit applications.

With the MDR UK 2019, the manufacturer who is not established in the United Kingdom but wants to place products on the market there must designate a responsible British person (“responsible person”) to act on his behalf. The responsible person proves their status either by means of a designation letter or a signed contract. This confirms that the responsible person is acting with the consent of the foreign manufacturer and in accordance with the legislation for products on the UK market.

Conclusion

Brexit will have lasting effects on the entire medical device industry. This affects both British manufacturers whose products are to be marketed within the EU and who will therefore need an EC Rep in the future, as well as manufacturers from the EU-27 countries who will in future cooperate with a British one for the sale of new products in the United Kingdom responsible person. Non-European manufacturers with EC Rep in the United Kingdom will have to appoint a new authorized representative in one of the EU-27 countries. The smooth (further) distribution of products within the United Kingdom and the EU-27 therefore necessarily requires structural adjustments to previous cooperation models. It is unavoidable to deal with the question of changing the previous authorized representative, including the associated adjustments to product information and changed registration obligations.

[April 2019]