The UK has issued a clarification on CE marking for the medical device industry after confusion arose after it announced indefinite CE recognition for manufacturers beyond the 2024 deadline.
The Department for Business and Trade made announcements earlier in the week for manufacturers in what it called a package of smarter regulations designed to ease business burdens and help grow the economy, with British firms able to continue the use of CE marking alongside UKCA.
The Medicines and Healthcare Regulatory Agency (MHRA) released a statement on CE marking recognition for medical devices and in vitro diagnostics.
The extended recognition of CE marking announced does not apply to medical devices or IVDs.
The government has already put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain market. More specifically, legislation now enables CE marked medical devices to be placed on the Great Britain market to the following timelines:
- general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2028
- in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2030, and
- general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.