As a result of Brexit, the In Vitro Diagnostic Medical Device Regulations (IVDR) will not apply to Great Britain (England, Wales and Scotland). Unlike Great Britain, the IVDR will apply in Northern Ireland from 26 May 2022.
Guidance issued by the Medicines and Healthcare products Regulatory Agency (MHRA) on December 31st 2020, clarifies the regulation of medical devices (inclusive of in vitro diagnostic medical devices and active implantable medical devices) in Great Britain.
Of note for medical device manufacturers entering the Great Britain market, is the grace period for registering devices with the MHRA; grace period dates span from May 2021 to January 2022 for different classes of devices. CE marking will continue to be recognized in Great Britain until June 2023, from July 1st 2023, a UKCA (UK Conformity Assessed) mark will be required. UK Approved Bodies, designated by the MHRA will conduct UKCA mark assessments; device manufacturers will also need to appoint a single UK Responsible Person who will be responsible for the product in Great Britain.
Boston Healthcare continues to track implications of Brexit and IVDR on the regulation of medical devices, ensuring manufacturers are equipped to factor in additional time and resources needed to comply with differing requirements between the EU and Great Britain. If your plans include an EU medical device launch in 2021 or beyond, contact us for assistance during your launch planning.