Press releases
EU Deadline for Class D devices draws closer: IMed Consultancy launches new guide on IVDs for tardy manufacturers
The deadline to certify Class D devices under the EU IVDR is around the corner: get ready before 26 May 2025
Oxford, January 16th, 2024 – IMed Consultancy, a rising regulatory and compliance consultancy provider with proven experience supporting UK and international medical device and in-vitro device manufacturers launch and maintain their products on global markets, today launches its new freely available 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, freely available here: https://imedconsultancy.com, 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.
About IMed Consultancy
Founded in 2012, IMed Consultancy offers a wide range of regulatory and compliance services to the medical technology industry supporting medical device and in vitro medical device manufacturers through all stages of the product lifecycle from: concept and design consultancy through to providing resources and strategic counsel regarding clinical studies and post market surveillance activities. IMed Consultancy’s team of highly skilled and experienced medical regulatory professionals offer an outstanding yet accessible global regulatory service. With over 50 years of combined hands-on problem-solving expertise, our remit is truly global, ensuring that client devices are successfully launched and maintained in total compliance in the UK, EU and internationally.
For more information visit www.imedconsultancy.com
The deadline to certify Class D devices under the EU IVDR is around the corner: get ready before 26 May 2025
Oxford, January 16th, 2024 – IMed Consultancy, a rising regulatory and compliance consultancy provider with proven experience supporting UK and international medical device and in-vitro device manufacturers launch and maintain their products on global markets, today launches its new freely available 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, freely available here: https://imedconsultancy.com, 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.
About IMed Consultancy
Founded in 2012, IMed Consultancy offers a wide range of regulatory and compliance services to the medical technology industry supporting medical device and in vitro medical device manufacturers through all stages of the product lifecycle from: concept and design consultancy through to providing resources and strategic counsel regarding clinical studies and post market surveillance activities. IMed Consultancy’s team of highly skilled and experienced medical regulatory professionals offer an outstanding yet accessible global regulatory service. With over 50 years of combined hands-on problem-solving expertise, our remit is truly global, ensuring that client devices are successfully launched and maintained in total compliance in the UK, EU and internationally.
For more information visit www.imedconsultancy.com
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