If there is no deal with the European Union (EU) concerning the terms of the UK’s withdrawal from the EU, the UK’s current collaboration in the European regulatory network for Medical Devices and IVDs would end, and the Medicines and Healthcare products Regulatory Agency (MHRA) would take on the responsibilities for the UK market currently undertaken through the EU system.
Following on the further guidance note on the regulation of medicines, Medical Devices and clinical trials if there’s no Brexit deal published on January 3rd 2019, the MHRA has recently issued The Medical Devices (amendment) (EU exit) Regulations 2019 (UK MDR 2019) and a Guidance note on Regulating Medical Devices in the event of a no deal scenario, which will apply from exit day subject to the The Medical Devices (amendment) (EU exit) Regulations 2019 being passed.
These documents set out how Medical Devices will be regulated in the UK in a no deal scenario; and provide details on Medical Devices and IVDs product certification and registration requirements with the MHRA, as well as CE marking applicability, among others.
After March 29th 2019 and in case of a no-deal scenario, the Directive 90/385/EEC on Active Implantable Medical Devices (EU AIMDD), Directive 93/42/EEC on Medical Devices (EU MDD) and Directive 98/79/EC on In Vitro Diagnostic Medical Devices (EU IVDD) will remain applicable the UK through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). The UK MDR 2019 will amend the UK MDR 2002 to reflect the new regime according to UK’s departure from the EU, and will also transpose all the key elements recently introduced in the Regulation 2017/745 on Medical Devices (EU MDR) and Regulation 2017/746 On In Vitro Diagnostic Medical Devices (EU IVDR), which will be brought into force in line with the transitional deadlines established by the EU for the full implementation of those two Regulations.
Moreover, the MHRA is expected to perform market surveillance of Medical Devices on the UK market and be able to take a decision over the marketing and supplying of a device in the UK, regardless of the position of the European regulatory network, or any post-exit decision of the European Court of Justice.
It is important to remind that these proposals are still subject to parliamentary approval of the changes to the relevant statutory instruments that are required to bring these proposals into law and this notice is meant for guidance only.
The latest Brexit news and European Regulation implementation resources are available in Magellan Device Compliance Platform, please contact our team and join us at the International Dental Show (IDS), the leading global trade fair for the dental community (Cologne, Germany, from 12 – 16 March 2019), to know more details on how Magellan can help you being abreast of all of them!