Even though there is a fair amount of turmoil regarding Brexit, MHRA is getting ready for a worst-case scenario, a no-deal Brexit.
In this sense, United Kingdom’s national competent authority has prepared a guidance document to assess how medical devices will be regulated in case UK leaves the EU without an agreement regarding the management of medicines and medical devices. This guidance document can be found by following the link below:
As stated in the guidance document, the EU Medical Devices (Amendment etc.) (EU exit) Regulations 2019 (UK MDR 2019) will amend the current national legislation on medical devices (UK MDR 2002) since the departure day. This amendment will mostly align the national UK regulation on medical devices with the current Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 2017 on medical devices (MDR).
Even though most of the requirements for the medical devices will remain the same, as UK will no longer be part of EU, there will be several issues to assess:
- Manufacturers from EU will need a UK Responsible person, who will act on its behalf;
- Any UK-based Authorized Representative will no longer be recognized under EU law;
- CE marked devices will be accepted in UK, but the importer of the device will have to verify the marking of the device.
- UK-based notified bodies will only be recognized in the UK.
Additionally, all products (either MD or IVD) placed on the UK market will have to be registered with the MHRA. As it is assumed that it will be difficult for manufacturers to handle these registrations in due time, a grace period has been stablished for each class of device:
- Class III/IIb implantable/ Active implantable/ IVD List A: 4 months
- Class IIb non-implantable/ Class IIa/IVD List B/ Self test IVD: 8 months
- Class I/ General IVDs/ Class A IVDs: 12 months.
Are you prepared for a no-deal Brexit scenario?
ASPHALION, an International Scientific and Regulatory Affairs Consultancy with extensive knowledge on medical devices (and with offices throughout Europe and UK) can ease your path through this turbulent transition, assessing you on each step of the way.
Contact us at [email protected] to obtain specialized advisory and support.