While the European Union (EU) remains hard at work in developing its new regulatory framework for medical devices under the MDR and IVDR, the UK has extended deadlines for the use of currently CE-marked medical devices to be sold in Great Britain (GB) and provided information on transition timelines. Under this transition:
- Devices approved under the EU Medical Devices Directive (EU MDD) or EU Active Implantable Medical Devices Directive (EU AIMDD) are allowed to be placed on the Great Britain market until the expiration of the certificate or June 30, 2028, whichever is sooner
- In vitro diagnostic medical devices (IVDs) approved under the EU In Vitro Diagnostic Medical Devices Directive (EU IVDD) will be allowed to be placed on the market until the expiration of the certificate or June 30, 2030, whichever is sooner
- Devices, including custom-made, approved under the EU Medical Devices Regulation (EU MDR) and IVDs approved under the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR) until the expiration of the certificate or June 30, 2030
- Class I sterile devices or Class I devices with a measuring function can be placed on the GB market until June 30, 2028 provided each has a valid MDD certificate
Additionally, self-declared CE-marked Class I devices will be allowed to be placed on the GB market beyond June 30, 2023 if they are either self-declared against EU MDR requirements (until June 30, 2030) or were self-declared against EU MDD requirements before May 26, 2021.
It also provides that you can place a Class I medical device which has a sterile or measuring function with a valid EU MDD certificate on the GB market until 30 June 2028.
Although no longer a member of the EU, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has published its Implementation of the Future Regulations which includes eleven core regulations which they hope will foster more international collaboration and offer increased focus on patients in response to changing technological advances. Examples of these core regulations include:
- The use of a unique device identifier (UDI) system
- Up-classifying implantable medical devices and requiring implant cards for patients
- Aligning the essential requirements for devices with those of the EU’s General Safety and Performance Requirements (GSPR)
- Implementing new requirements for clinical investigations
- Clarification of the requirements for economic operators and adding the need for a Person Qualified in Regulatory Compliance (similar to the PRRC under the EU Regulations)
- Developing a system for international recognition to increase speed to market for manufacturers who’ve achieved approval from other regulators, including those having Medical Device Single Audit Program (MDSAP) certificates
In addition to the new regulations document, the MHRA also developed a graphical roadmap that represents these timelines for medical device manufacturers to use to avoid the loss of a vast number of devices from the GB market. The roadmap takes into account milestones, both achieved and planned, for the period of 2021-2025. An important area within the roadmap is the work done on regulations for SaMD, and artificial intelligence and machine learning (AI/ML) products and their associated guidance documents.
