Just like any other industry, Brexit has impacted the Medical Devices industry too. The political situation would require all the stakeholders including manufacturers, importers, distributors and Notified Bodies to adapt to the new Regulatory landscape shaping up in the Europe.
The new Medical Device Regulations in the United Kingdom would be in effect from 1st January 2021 and have a grace period to a maximum of a year with different timelines applicable for different classes of devices. The Regulatory requirements are going to be different in Northern Ireland, Great Britain and the European Union. Device manufacturers intending to place their devices in both the UK and the EU markets shall have two representatives appointed, one in each of the markets, to be called as United Kingdom Representative Person (UKRP) and European Authorized Representative (EAR).
Devices shall carry UKCA mark on their labels to be marketed in the UK. The requirement will be voluntary till the end of June 2023 and would be mandatory after the forementioned date. Considering all the three (3) regions, there would be three (3) different types of makings that would be prevailing.
Freyr can support in evaluating your business needs, markets in scope and devise best possible strategy that would be economical and compliant to all the applicable regulations. Freyr also provides services for implementation of finalized Regulatory strategy enabling easy transition towards compliance with new regulations shaping up as a result of Brexit.
Know further on implications of Brexit on Medical Device industry here.