MAP have prepared summaries of several of the Government’s technical notes, preparing the UK for a no deal Brexit. Please contact MAP if you would like to read the summaries we have published on the MAP BioPharma pages.
Below, we have captured the key points in the Government’s documents for MedTech developers, from the technical note on how medicines would be regulated after a no deal Brexit.
Current Legal System
In the UK, all medical devices must comply with the EU’s CE marking legislation. They are covered under three EU Directives:
- Active Implantable Medical Devices Directive
- Medical Devices Directive
- In Vitro Diagnostic Medical Devices Directive
In addition, higher-risk medical devices (Class IIa, IIb and III devices and in vitro diagnostic devices in list A and list B in Annex II of the EU Directive, plus self-testing devices) must obtain certification from the appropriate EU Notified Body (MHRA in the UK), an independent conformity assessment authority, conditional upon two audits by other national bodies as well as the European Commission.
Post-Brexit Legal System if no deal is reached
The UK will continue to recognise medical devices with CE-mark approval unless new requirements are outlined, in which case businesses would be given adequate time to implement any changes. Continuous compliance will include recognising all key provisions of the Medical Devices Regulation and the In Vitro Diagnostic Regulations, coming into force in 2020 and 2022 respectively.
Importantly, the UK’s formal presence at EU committees would cease.
Demonstrating device’s compliance
The Government has confirmed that for some limited time after Brexit, the CE Mark would still be recognised as the criterium for demonstrating EU compliance. A device would be accepted on the UK market once it would demonstrate its compliance with all EU requirements, including certification by EU Notified Bodies (except the lowest risk devices).
UK Notified Bodies would no longer have the authority to assess the conformity of medical devices and grant the CE mark for EU market.
Further direction of introducing devices into the UK market would be subject to consultation.
Post-market devices surveillance
Post-market safety information is currently shared across all member states of the European regulatory network (EEA plus Turkey and Switzerland). This means that any discrepancy over device’s marketing can be escalated to regulator forums, e.g. the Medical Devices Coordination Group or even the European Commission and the Court of Justice of the European Union.
In a no-deal scenario, the MHRA would continue to perform its functions in this respect without the overarching European authorities.