Below is an overview of the July 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., MHRA updates on international reliance and the possible indefinite recognition of CE Marking.

EU Commission Updates

CAMD Statement on EU Regulatory Reform

The CAMD released a joint statement on the future of the EU’s medical device regulatory framework: HERE

The statement highlights several priorities:

While the statement supports the Commission’s current streamlining efforts, it also proposes measures beyond “better implementation” of MDR/IVDR. Essentially, they indicate that the current system is too fragmented and under-resourced to function effectively as is, and the underlying structure also requires reform.

The CAMD acknowledges that achieving this will require legislative changes beyond the MDR/IVDR and new resources. However, it does not detail how such reforms might be delivered, who would fund them, or what structures would be created.

Expert Panels: Orphan & Paediatric Devices

Commission Implementing Decision (EU) 2025/1324 was published on 8 July 2025: HERE

It puts in place new Expert Panels for orphan devices (rare disease that fulfills an unmet need or adds value) and paediatric devices. Expert panels are independent groups of specialists set up by the Commission, to provide scientific, technical, and clinical advice to support implementation of the regulations.

These were set-up for orphan and paediatric devices where clinical data sets are very small (few patients, few studies), lack precedent, and involve high-stakes populations. The Expert Panels can support industry in the following ways:

If your portfolio includes orphan or paediatric devices, expect new expert panel scrutiny, as well as opportunities for early advice.

MDCG 2025-7: Master UDI-DI for Contact Lenses & Spectacles

MDCG 2025-7, published 10 July 2025, is available: HERE

The guidance notes that all devices, including contact lenses and spectacles, will need to be registered in EUDAMED* starting early 2026. However, the requirement to utilize Master UDI-DI does not come into force until after that date. Master UDI-DI requirements comes into force starting 9 November 2026 for contact lenses, and ~September 2028 for spectacles. Therefore, MDCG 2025-7 strongly encourages companies to implement the requirements early, rather than waiting until the mandatory deadline.

*This is the current projected timeframe that its use will become mandatory, followed by a 1-year transition period.

Master UDI-DI for Contact Lenses Extended

Delegated Regulation (EU) 2025/788, to extend the contact lens Master UDI-DI compliance date by one year. It is available: HERE

Companies now have until 9 November 2026 to implement Master UDI-DI into their UDI system. However, companies are strongly recommended to voluntarily comply early, so that their EUDAMED entries are done under the Master UDI-DI option.

MHRA Updates

UK Aligns with EU IVD Common Specifications

The MHRA advised it will amend Great Britain’s legislation to 1) incorporate EU Common Specifications for high-risk IVDs, and 2) repeal the regulations on Coronavirus Test Device Approvals (CTDA). The announcement is available: HERE

This was based on feedback received under its recent open consultation: HERE

Survey on the Medicines Act

The MHRA has opened a survey to evaluate whether the legislation is operating as intended now, if it continues to effectively protect public health, and avoids imposing unnecessary or excessive regulatory burdens. You can participate: HERE

This is part of its statutory obligation to do so every five years. The survey is open through 19 September 2025.

Team Notified Body (NB) Updates

MDR TDF Training: 17 Sep 2025

Team-NB is another session of its MDR Technical Documentation File training program. Additional details, including fees and how to sign-up, are available: HERE

Position Paper: IVD Orphan Devices

Team-NB published a new position paper on orphan IVDs (IVDs intended for rare diseases): HERE

Since the IVDR doesn’t currently define them, Team-NB proposes applying a prevalence threshold of not more than 1 in 2,000 people in the EU. Plus, the same unmet need/value criteria as orphan medical devices.

Because clinical data will be scarce, the paper suggests greater flexibility: reliance on real-world evidence, expert opinion, and legacy/off-label data, alongside conditional certification with strong post-market follow-up.

NB Perspective on the MDR/IVDR

Team-NB and NBCH-Med published a paper on their ‘Perspective on Future Governance in the EU Medical Device Sector’, available: HERE

They are calling for creation of a Medical Device Coordination Office (MDCO) at EU level. They propose that MDCO would:

This is a self-positioning piece, mainly reinforcing the role and authority of Notified Bodies within EU governance. It outlines how NBs want the system reshaped to elevate their role in future decision-making.

MedTech Europe Updates

MedTech Europe IVDR sampling

MedTech Europe has published a position paper arguing that sampling requirements for IVD conformity assessments under the IVDR should be applied using a risk-based approach. It is available: HERE

The paper notes that current sampling practices are often too rigid and resource-intensive, particularly for lower-risk or high-volume IVDs. It recommends that Notified Bodies should adapt sampling based on:

They suggest Notified Bodies should take a more practical, risk-based approach. In practice, this could then lower costs and barriers and help keep more IVDs on the market as IVDR deadlines approach.