March 29th 2019 is fast approaching, and the UK is currently facing to leave the EU without a deal in place. For this reason, the UK government has been publishing technical notices for businesses and citizens to understand what to expect in a no deal scenario. We will focus on the recently published MHRA official guidance with regard to the regulation of medicines, medical devices and clinical trials in case there is no Brexit deal. Find below the most remarkable points:
– CE-marked medical devices approved for the EU market will be recognised by the UK for a time-limited period. During this period, devices will be accepted on the UK market if they meet all EU requirements.
If the above changes, the MHRA will provide adequate time for businesses to implement the new requirements.
– The UK will comply with all key elements of the new MDR and IVDR.
– Formal UK presence at EU committees in respect of devices will cease.
– UK-based Notified Bodies would no longer be able to assess the conformity of devices to receive the CE mark and enter the EU market.
– The MHRA would continue to perform national post-market surveillance of medical devices on the UK market. The MHRA will also be able to take a national decision over the marketing of a device in the UK, regardless of the position of the European regulatory network, or any decision of the CJEU.
– As the new EU Clinical Trial Regulation (CTR) 536/2014 will not be in force at the date the UK exits the European Union, the EU CTR will not be incorporated into the UK law. However, certain extent of adaption to the EU CTR is envisaged at a later stage.
– After Brexit date, modified 2004 Regulations will remain in force in the UK.
Obelis has officially established a new company in the UK – Obelis UK Ltd – to serve as a UK Responsible Person for our clients who will need a representative in the UK in the case of a ‘no deal’ Brexit. Please do not hesitate to contact us!