The proposal introduces wide-ranging changes across the device lifecycle. It focuses on simplification and proportionality, including more flexible requirements for the Person Responsible for Regulatory Compliance, a move away from fixed certificate validity periods, and more risk-based, proportionate re-certification through periodic reviews. It also broadens the types of clinical and non-clinical data that may be used to demonstrate compliance and introduces the concept of well-established technologies with adapted requirements.
Administrative burden is further reduced through changes to post-market obligations, including less frequent updates of PSURs, a reduced scope for SS(C)Ps, extended timelines for reporting certain serious incidents, and clearer rules on changes after certification, including the possibility of agreed change control plans.
To support innovation and availability, the proposal introduces dedicated pathways for breakthrough and orphan devices, more flexible rules for in-house devices under both MDR and IVDR, regulatory sandboxes, and new provisions addressing public health emergencies. Several changes are also intended to improve predictability and cost-efficiency of conformity assessment, such as reduced involvement of notified bodies for lower-risk devices, fewer and more targeted audits, adjusted consultation procedures, and mandatory fee reductions for micro and small manufacturers.
The proposal also strengthens coordination within the EU regulatory system, enhances the role of expert panels and EMA support, and advances further digitalisation, including electronic submissions, digital documentation, and expanded use of EUDAMED. Finally, it aligns MDR and IVDR with other Union legislation in areas such as combined studies, cybersecurity, nanomaterials, and substances of human origin
It is important to note that this is a legislative proposal. It now enters the ordinary legislative procedure, during which both the Member States and the European Parliament will review the text and may introduce significant amendments before any changes become law.
What does this mean for you?
If adopted, this proposal could ease several MDR and IVDR requirements by making certification and oversight more proportionate and risk-based. Manufacturers may benefit from reduced administrative burden, greater flexibility in the use of clinical and non-clinical data, and more predictable interactions with notified bodies, particularly for SMEs, innovative devices, and well-established technologies.
For now, this is only a proposal, but it is one to watch closely, as it could meaningfully affect certification strategies and lifecycle management once the legislative process progresses.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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