InnoScot Health states EU amendment to medical device regulation offers a “temporary solution”
A new EU amendment aimed at avoiding shortages of vital in vitro diagnostics (IVDs) without compromising safety has been welcomed by an expert in medical device regulation.
The amendment to the In Vitro Diagnostic Medical Device Regulation (IVDR) was recently adopted by the European Council and helps to prevent regional IVD shortages resulting from delays to conformity assessment deadlines.
The European Council move also amends the position that manufacturers are not required to register their devices on the European database on medical devices (EUDAMED) until all six modules are available and requires manufacturers to provide information about their products in the available EUDAMED modules.
Furthermore – and significantly for manufacturers – they are now required to give six-month notifications to relevant authorities, health institutions, healthcare professionals, and economic operators if they anticipate interruption of supply of devices which may result in harm to patients.
Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, commented: “This is a positive change aimed at preventing interruption of supply of IVDs due to changes in the regulations.
“Extending the deadline for transitioning to the new system while taking steps to avoid shortages of critical IVDs is to be welcomed amid recurrent concerns that products were not transitioning quickly enough to IVDR under the previous deadlines.
“It is positive to see the European Commission’s proposals for updating the IVDR deadlines now endorsed by the EU Council after agreement was reached with the European Parliament, in turn giving manufacturers more time to recertify their products.”
However, she added: “At the same time, it is clear that much work is yet to be done, and it has to be said that this fourth extension represents a temporary solution – particularly considering a number of products which are currently on the market are yet to comply with the new IVDR rules.
“We also echo others’ concerns over challenges persisting and practical solutions being required rather than further extensions.”
The amended regulation stipulates that class D devices need to come into conformance by 31 December 2027, class C devices by 31 December 2028, and class B and class A sterile devices by 31 December 2029.
Currently, IVDs compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain market up until the expiry of certificate or 30 June 2030, while general medical devices – including custom-made devices – compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the IVDR can be placed on the Great Britain market up until 30 June 2030.
The InnoScot Health team offers skilled regulatory experts, dispensing advice and support to healthcare innovators across Scotland. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive and Medical Device Regulation.
With more than 20 years’ experience in medical device development, Elaine Gemmell – last year awarded the title of Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University – is a certified ISO 13485/ISO 9001 Lead Auditor and has experience of regulatory approval and CE marking for medical devices.
