3) Has been affixed with CE marking (special rules apply to devices designed or designed for clinical examinations) Join Dr Jayanth Katta, head of the UK`s regulatory body, Regulatory Services, to hear the latest updates on Brexit and the new UKIty Assessed Mark (UKCA) for medical devices. Due to ongoing Brexit trade negotiations and unpredictable results, products, including medical devices and IVDs identified by a notified body in the UK East, may face customs clearance problems at EU borders after 1 January 2021. The Independent Medicines and Medical Devices Safety Review, which presented its report last July, stressed the importance of stricter regulation, which is more important to protect patients. We are committed to improving the standards and control of medical devices for British patients. This is made possible by the powers currently created by the Medicines and Medical Devices Act. If you are currently marking your medical device on the basis of self-certification, you can do so after 1 January 2021 and place your device on the UK market until 30 June 2023. With regard to self-certification devices (generic Class I and IVD medical devices), the manufacturer can complete the UK compliance assessment procedure and affix the UKCA symbol to its devices. Until 30 June 2023, manufacturers of these devices can continue to rely on the EU CE marking for products on the UK market. On 13 March 2020, the European Commission published a revised and consolidated stakeholder communication and FAQ 2019 document to provide additional information on the impact of a non-agreed Brexit on medical devices (and other products covered by the new approach legislation). This document is intended to provide advice to stakeholders and to highlight some of the effects on certification, labelling, representation and delivery in the event of an agreement. This document is available on the European Commission`s website. Manufacturers must meet applicable product identification and compliance assessment requirements for medical devices, including IVDs. Further information is available below for guidelines for UKCA`s marking and compliance assessment bodies and guidelines for EC markings and notified bodies.
Manufacturers based outside the EU can no longer rely on UK-based authorised agents for devices marketed in the EU. You must appoint an agent in the EEA. At the moment, medical devices are governed by Directive 90 / 385 / EEC (regarding active implantable medical devices – EU AIMDD), Directive 93 / 42 / EEC (regarding medical devices – EU MDD) and Directive 98 / 79 / EC (in vitro medical devices – IVDD) which are transposed into UK legislation by the Medical Devices Regulation 2002 (SI 2002 No. 618). (UK MDR 2002). These regulations (in the form they will be in place on 1 January 2021) will remain in force in the UK after the transition period. In accordance with the Northern Ireland Protocol, the rules for marketing medical devices will deviate from those applicable in the United Kingdom from 1 January 2021. If the UK and the EU fail to reach agreement on the terms of their future relations after the transition or transposition period, or if the UK regulatory system deviates significantly from that of the EU, considerations similar to those that apply in the event that the withdrawal agreement has not been concluded (non-agreement scenario) may still be valid. This practical note is based mainly on guidelines originally issued by the European Commission and the Medicines and Health Products Regulatory Agency (MHRA) for a non-agreement scenario, but which were discussed during the negotiations.