Impacts of a (’no-deal’) Brexit on the medical devices industry
Consequences of the Brexit for companies with their principal place of business in the United Kingdom
For manufacturers of medical devices who have their principal place of business in the United Kingdom and wish to continue to place their products on the market in the Union, this means that as from the date on which Britain leaves the EU (set for 29 March 2019) they require an authorised representative within the EU-27.
Consequences of the Brexit for companies which have their principal place of business outside the EU and a British authorised representative
As from the time of the Brexit, manufacturers of medical devices who have up to now worked together with a British EC REP will be obliged to seek a new authorised representative outside the United Kingdom in one of the EU-27 states. Representation in the EU by an authorised representative in the United Kingdom will no longer be possible from the moment Britain leaves the Union.
Consequences of the Brexit for products on the EU-27 market and the British market which do not (yet) have a CE marking
As as result of the Brexit, the Medicines and Healthcare Products Regulatory Agency (MHRA) expects that after 29 March 2019 the EU-27 will no longer accept certificates issued by British notified bodies. That means that manufacturers who want to place products on the market in the EU-27 must apply for recertification by a notified body in the EU-27.
For the British market, by contrast, the MHRA intends to give the existing British notified bodies an ongoing legal status in order to acknowledge the validity of certificates they issue before 29 March 2019. Certificates issued by the British notified bodies for products which have been placed on the British market will thus continue to be valid after Britain’s departure.
With regard to new products which have not yet been placed on the market but are intended to be placed on the market in Britain in the future, manufacturers are at first recommended only to cooperate with a notified body in a state of the EU-27.
If a product is affixed with the CE marking in accordance with the EU Directives or EU regulations, it may continue to be sold on the British and EU-27 markets.
Registration of medical devices in the United Kingdom after the Brexit
The so-called Medical Device Regulation 2002 (MDR UK 2002) implements Directives 90/385/EEC, 93/42/EEC and 98/79/EC in national British law. Following the draft of MDR UK 2019, amendments will be carried out on MDR UK 2002 in particular, which will be necessary when the departure of the United Kingdom from the EU comes into effect.
As from 29 March 2019, all products placed on the British market will have to be registered with the MHRA. Registration will only be possible if evidence of a ‘registered office’ in the United Kingdom is provided. Depending on the risk category of the product, there will be certain transitional periods for these registration obligations.
The United Kingdom will continue to accept existing authorisations for clinical studies, so that it will not be necessary to re-submit applications in respect of these.
With the MDR UK 2019, a manufacturer who does not have a dealership in the United Kingdom but wishes to place products on the market there must appoint a responsible British person (‘responsible person’) to act on his behalf. The responsible person provides evidence of his or her status by means of a letter of appointment or signed contract. This provides confirmation that the responsible person is acting for products on the British market with the approval of the foreign manufacturer and in harmony with the legislation.
The Brexit will have lasting impacts on the whole of the medical devices industry. Those affected will include both British manufacturers, whose products are intended to be placed on the market in the EU and who therefore need an EC REP in the future, and manufacturers from the EU-27 states, who will in future be dependent on cooperation with a British responsible person for the sale of new products in the United Kingdom. Non-European manufacturers with an EC REP in the United Kingdom will be obliged to appoint a new authorised representative in one of the EU-27 states. The smooth continuation of the sale of products in the United Kingdom and the EU-27 states thus necessitates structural adjustments to the previous cooperation models. The need to come to terms with the issue of changing the previous authorised representative, including the modifications to product information and altered registration obligations that accompany it, will be unavoidable.back