UK Government publishes EU Exit Regulation for Medical Devices

Your Consultant on UK Regulation

As the UK is preparing its withdrawal from the European Union, EU law is currently being converted into a new type of domestic (UK) law. The type of law that will become effective in the UK on the exit day, currently scheduled on October 31st2019, is called “retained EU law”. By removal of the constitutional basis of EU law affecting the UK, the aim of the “retained EU law” is to offer legal certainty in the post-Brexit period. By way of explanation, this means that the UK will be adopting a set of rules and laws that is initially as close as possible to the EU rules currently applicable in the UK.

In the field of medical devices, the UK government has recently published the Medical Device Regulations (EU Exit) 2019. This regulation amends the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) which currently govern the UK medical device industry. Notable amendments in this EU exit legislation concern the definition of the Authorized Representative, Notified Body and Designated Standards.

The UK Medical Device Regulation 2019 also adds the definition and role of a “UK responsible person” defined as a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations.

As further specified in the new UK regulation,manufacturers without an UK registered address seeking to place a medical device on the UK market will have to inform UK authorities about the UK address where their administrative details and technical information about its devices is being held available.

At Obelis UK, we will be able to serve our clients as UK responsible person. Would you like to know more about Obelis UK and how Brexit will affect the compliance process of your medical devices? Contact us for further information about this topic.