IMed Consultancy launches new guide on IVDs for manufacturers

IMed Consultancy, a regulatory and compliance consultancy provider with experience supporting UK and international medical device and in-vitro device manufacturers launch and maintain their products on global markets, has launched its new whitepaper on In-Vitro Diagnostics (IVDs).

The paper analyses the key role of IVDs in supporting healthcare systems with early diagnosis to tackle common and rising diseases and comes at a critical time for manufacturers that still have not started the process of registering legacy devices under the EU IVDR.

IMed’s latest whitepaper explores the role of IVDs and calls for suitable regulatory perspectives for their adoption in order to support increased market access.

“The deadline to certify Class D devices under the Invitro Diagnostic Medical Devices Regulation (EU) 2017/746 (‘IVDR’) is 26 May 2025. With estimates suggesting that the entire certification process for legacy products could take between 12 and 18 months, depending on risk class, status and maturity of the technical documentation and QMS, as well as the availability of a Notified Body, manufacturers need to act urgently to ensure they are not cut out of the market,” explains Jonathan Ripley, IVD and MD consulting services director at IMed Consultancy, “Anecdotal evidence suggest that this deadline has not been prioritised by far too many IVD manufacturers that now need to act swiftly if they want to provide continuity on the EU market for their products and their users.”

Both in the UK and in Europe, the debate surrounding the critical importance of enabling more IVDs onto the market to “detect and contrast” diseases at their earliest stages is hotting up. In addition to better outcomes, early intervention also results in lower treatment costs for health systems, making it imperative for national and international institutions to do as much as possible to improve access to IVDs. However, the volatile and evolving regulatory environment poses a steep challenge, both in the EU and in the UK.

“As healthcare is moving towards a more proactive form of prescribing and IVDs are proving to be indispensable tools to enable this, IMed felt the need to draft this insightful paper to explore and highlight the importance of IVDs in this new landscape, aiding manufacturers in the process of achieving compliance.” continues Ripley.