In a decision associated with the United Kingdom’s withdrawal from the European Union, the UK’s Medicines & Healthcare products Regulatory Agency issued updated guidance with new links to notified bodies permitted to undertake conformity assessments of medical devices in the UK.
Conformity assessments are required before a CE Mark is issued for marketing authorization. The following notified bodies can conduct conformity assessments in the UK:
- Amtac Certification Services;
- BSI Healthcare;
- Lloyd’s Register Quality Assurance;
- SGS United Kingdom; and
- UL International (UK).
The MHRA and the European Medicines Agency are very intertwined, so it will be especially difficult for the MHRA to make a clean break, but it’s unclear how the UK regulatory system will work within the EU regulatory scheme as the UK government negotiates the terms of its withdrawal from the EU.
BSI said in a statement that its role as an EU notified body won’t change following the UK decision to leave the EU. The standards organization is working closely with the MHRA and the Department of Health to ensure “continuity of our full scope designation” as a notified body for medical devices.
BSI plans to use the existing mechanisms for non-EU member states to fully participate as EU Notified Bodies – and it cites examples of designated organizations in Norway, Switzerland and Australia via mutual recognition agreements, all of whom are recognized as Notified Bodies for the purposes of the EU legislation.
BSI anticipates that the UK will continue to participate in the European standards system post-Brexit.
Remaining as a full member would bring maximum benefit to the UK economy and society in its new status outside the EU because reciprocity of market access with European countries and the maintenance of a unified domestic market structure across the UK facilitate trade and reduce complexity for SMEs and consumers, BSI said.
BSI expects to be in the first wave of notified bodies designated under the recently passed EU Medical Device and IVD Regulations, and it is investing heavily to meet the new requirements. “Going forward we aim to provide a seamless transition within a new designation recognition mechanism as part of any UK-EU framework,” the standards group said.
The EU’s new Medical Device Regulation has introduced significant compliance headaches for manufacturers — including new harmonized standards, classification rules, and conformity assessment procedures.
Some devices will have to be reclassified under the MDR’s new classification rules. There are four device classifications (I, IIa, IIb, and III) and four groups of classification rules encompassing non-invasive devices, invasive devices, active devices, and a catch-all category of special rules.
Each device class has more than one conformity assessment pathway. There are specific requirements for Class III implantable and Class IIb implantable devices, as well as separate requirements for Class I sterile devices, reusable surgical instruments, and devices that have a measuring function.