Medical devices in the event of a no-deal Brexit: What is next?

Due to intensive negotiations in which all parties concerned have not yet reached an agreement, the possibility exists that the October deadline will be extended.

This could lead to far reaching consequences for all parties concerned both in the UK and EU. In the event of a no-deal Brexit, the competent authority of the UK, the Medicines and Healthcare products Regulatory Agency (MHRA), will take on the role and responsibilities which are currently undertaken by the European Union.

Other than a no-deal Brexit, it is also probable that the UK will request an extension of the negotiation period. If this is the case, the deadline for Brexit will be extended further in time. For these reasons it remains uncertain if and when the Brexit will ultimately be effective.

Legislation

Before the Brexit is finalized, medical devices are regulated in the UK following the European Directives and Regulations of medical devices. The current Directives (Directive 93/42/EEC, Directive 90/385/EEC and Directive 98/79/EC) are implemented in the national UK legislation (Medical Devices Regulations 2002 (UK MDR 2002)).

The UK intends to amend and implement the UK MDR 2002 to ensure that key elements of the EU Regulations on medical devices (Regulation 2017/745 and Regulation 2017/746) have been transposed.

Bringing a medical device onto the UK market

Manufacturers, that are established outside the UK, which are bringing medical devices onto the UK market shall appoint a UK Responsible Person. The UK Responsible Person must be established in the UK and acts on behalf of the manufacturer outside of the UK.

As only the manufacturer or a designated UK Responsible Person can legally place a device on the UK market, it is possible to assign more than one UK Responsible Persons. The term “Person” refers to either an individual or a legal person. The registration of a medical device in the UK shall be done with the MHRA by the manufacturer or the UK Responsible Person.