Post Brexit Market Access for Medical Devices
With a Brexit deal or no Brexit deal still on the cards, when either outcome comes into effect, the UK will be considered a third country. Countries which are located outside the EU are considered ‘third countries’. To ensure uninterrupted market access, it is advised for manufacturers to prepare for Brexit.
Implications for product on the Australian market:
The TGA will continue to recognise conformity assessments from UK based Notified Bodies for existing and new ARTG listings and applications. The TGA will recognise:
- Device certifications by UK notified bodies through 31 Dec 2020
- Conformity assessments from UK based notified bodies
There is a Mutual Recognition Agreement between the UK and Australian Government which addresses issues including recognition of certifications and conformity assessments, therefore there is no immediate impact on manufacturers certified by these notified bodies.
Implications for product on the European market:
Medical devices on the European market are regulated under Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), Medical Device Directive 93/42/EEC (MDD), Medical Device Regulation 2017/745/EU (MDR) and in vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD), in vitro Diagnostic Medical Devices regulation 2017/746/EU on In-Vitro Diagnostic Devices (IVDR) . UK notified bodies will no longer be considered EU notified bodies and no longer eligible to provide conformity assessment. Therefore, manufacturers who’s notified body was based in the UK must obtain new CE certification. Some Notified Bodies have set up offices within the EU-27 and the transfer can be managed through them.
Overseas manufactures require an authorised representative to place their product on the EU market, this role must be based in one of the EU-27 and no longer in the UK. It is advisable to have this implemented prior to Brexit.
The Local competent authority is responsible for the marketing surveillance of the product on the market in the EU.
Implications for products in the UK market:
Currently all product on the UK market are regulated per the EU legislation, which requires the manufacturer to place a CE mark on their product. In the event of a no deal these directives will be transposed into UK law as UK MDR 2002, the MHRA are responsible for this. However, there will be a grace period where the MHRA will allow product which conforms to the applicable EU legislation be placed on the UK market, the length of the grace period is not clear. UKAS accredited notified bodies will become ‘UK notified bodies’ and will assess products for the UK market against the UK essential requirements.
Manufacturers who have product available on the UK market must now assign a Responsible Person based in the UK, as the role of the Authorised Representative will no longer be recognised by the MHRA. This role has been created by the UK MDR 2002.
Product must be registered with the MHRA prior to placing the product on the UK market and the MHRA are responsible for market surveillance of medical devices.
Currently at this time, there is isn’t a Brexit deal in place and it is not known if a deal will be brokered or if the UK will leave the EU with no deal in place. The best approach is to be prepared for Brexit and to start putting some of the necessary actions in place.
TGA Medical Device Class I Update – Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices
November 9, 2020
June 4, 2020