New EMDN Resources: Helpdesk Now Live, MedTech Europe’s ‘Practical Guide’ & more
29 May 2025
UK MHRA Updates & Adds New Resources on Post-Market Surveillance (PMS) and Vigilance
11 June 2025Below is an overview of the May 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., updated MIR form published for Europe and Switzerland, EMDN Helpdesk Live, and EMDN code selection guidance.
MDCG Working Group Updates
February 2025 Meeting Minutes
- Main MDCG Working Group Minutes (without Stakeholders): HERE
- Main MDCG Working Group Minutes (with Stakeholders): HERE
Some items of note from the meetings:
- New guidance on the application of performance evaluation and clinical evidence requirements to orphan IVDs, was endorsed by the MDCG.
- Competent Authorities have started receiving supply interruption/discontinuation notifications under Article 10a.
- The EU survey on reliance notes that 100+ countries rely on the EU framework.
- Stakeholders support Europe becoming full members of MDSAP; the Commission agreed to continue gathering information about the impact of engaging with MDSAP.
April 2025 Meeting Minutes
- Main MDCG Working Group Minutes (without Stakeholders): HERE
- Main MDCG Working Group Minutes (with Stakeholders): HERE
Some items of note from the meetings:
- The Commission confirmed that the new eIFU allowance will only be applicable to medical devices intended for exclusive use by healthcare professionals.
- The EU will send delegates to the MDSAP Annual Forum taking place in Amsterdam 16-20 June 2025. Further, the Commission invited the MDCG to nominate experts to attend the combined MDSAP and MDR/IVDR audits, as a learning opportunity to test and assess the benefits and limitations of the process.
- The CAMD task force is still working on a decision tree diagram related to Article 10a requirements. In the meantime, MedTech Europe published this decision guide flowchart back in March 2025.
- Competent Authorities were requested to discuss the draft guidance on the status of app platforms.
- The open consultation to reevaluate the MDR/IVDR received “332 valid feedback entries…for the public consultation and 543 for the call for evidence”. Analysis of the public consultation data, and additional consultation exercises, will start soon.
- An update on the EUDAMED audit was provided, and its publication in the Official Journal of the EU is still planned for mid-2025 for the Actor, UDI/Devices, and NB & Certificates modules (click on images to enlarge; direct link to presentation is here).
Notified Body Certifications & Applications Status
The Commission published an update on the ‘Notified bodies survey on certifications and applications’: HERE
The survey is as of 31 October 2024. Some items of note:
- Application vs. Certification Gap
- 28,512 MDR applications lodged vs. only 10,554 certificates issued
- ~37% certification rate highlights ongoing bottlenecks
- Intent to Transition to MDR
- Volume and scope of MDR applications indicate most manufacturers do plan to transition legacy MDD/AIMDD devices to MDR
- 82% of NBs say applications cover >60% of legacy device scope
- Certification Timelines Remain Long
- QMS+Product certifications: ~56% of NBs report 13–18 months; ~25% take 19–24 months
- Manufacturers bear >50% of time burden in many cases (document revisions, clarifications)
- Application Quality Still a Major Issue
- Only 13 of 50 NBs report >50% of submissions are complete upon receipt
- Incomplete or poor-quality documentation continues to delay assessments
- Refusals Are Relatively Low
- 421 MDR applications refused (just ~1.5%), mostly due to scope mismatch, incomplete submissions, or incorrect classification
- IVDR Applications Are Still Low
- 2,341 IVDR applications lodged; 1,273 certificates issued
- Indicates most IVD manufacturers have not yet entered the certification process, likely due to extended legacy deadlines (2025–2027)
EUDAMED May Workshop Presentations
The Commission’s EUDAMED workshop occurred in Germany on 21 May 2025. The presentations are available: HERE
It was the first in a series of three planned for 2025. The next sessions are scheduled for 8 October 2025 in Rome, Italy and 3 December 2025 in Brussels, Belgium. They are conducted in a hybrid format, i.e., combination of in-person and virtual attendance.
Swiss Medtech Webinar
On 21 May 2025, Swiss MedTech gave a webinar on the recent US tariffs and their impact on the MedTech industry. The recording and presentation slides are available: HERE
First, the question on everyone’s mind: will medical devices to be exempt from the new tariffs? While industry groups are lobbying heavily, at this time, there is no indication that medical devices will be exempt. That said, more information will be available as tariff negotiations continue.
Other feedback from the webinar: While some of the webinar was targeted for companies located in Switzerland, there were several slides on practical examples for all medical device manufacturers. Some suggestions included:
- If you have a combo hardware/software device, consider charging separately for the software and hardware. Or, offering a subscription model for access to the software, as standalone software is generally not subject to tariffs.
- Note, the payment model still needs to make sense for your device, i.e., if you were previously charging €1,000 for the hardware/software combo, you likely cannot state you are just charging €1,000 for the software alone now and $0 for the hardware.
- Relocate portions of your manufacturing or assembly to the US.
- Note, if doing so, all the parts shipped to the US will still be subject to tariffs. So, you would need to consider how much this would save within the full supply chain.
- Reduce the cost of physical goods and add services related to the product, e.g., service and maintenance, subscription, training.
- Pass the tariff fee onto the customer in the US.
- Diversify your suppliers, as there may be countries where you can source parts from where the tariffs are not as high.
- If doing so, you should consider the impact it has on any Country of Origin (CoO) requirements.
MedTech Europe’s Proposal on MDR/IVDR Revision
MedTech Europe published suggested amendments to the MDR/IVDR: HERE
Background
There have been several well-documented issues on implementation of the MDR and IVDR. This resulted in EU Parliament voting on 23 October 2024 to revise the regulations. Since then the EU Commission opened a consultation to collect feedback on the effectiveness of the regulations and possible improvements that can be made.
Reforms are expected from the Commissions’ targeted evaluation of the MDR/IVDR. However, MedTech Europe is pushing for certain changes to take place before the broader legislative reform, which is expected in 2026.
Overview
MedTech Europe outlined four priority measures:
1) Make initial product approval faster, more efficient, predictable, and less costly.
Key Issues: The certification costs and review times have increased substantially under the MDR/IVDR. Further, expectations are inconsistent between Notified Bodies. This has resulted in some manufacturers removing some (or all) of their product portfolio from the market. Further, due to these difficulties, industry groups note that Europe is no longer a first-choice market for innovative products.
Suggestions: Establish clear and binding times for reviews, more structured dialogue, and transparency with Notified Bodies. For example, 1) publish reports on how long product and QMS approvals take, as well as the costs incurred per device type, 2) allow more dialogue early in the certification process, particularly on the level of clinical data required, and 3) make the approval process itself leaner and more efficient.
2) Make change notification processes faster, more efficient, predictable and less costly.
Key Issues: While the MDR and IVDR state that only important changes must be reported, in practice many Notified Bodies require that almost all changes be reported. Additionally, review by the Notified Body can take several months; meanwhile, manufacturers are not able to place the most updated version of their products on the market.
Suggestions: Categorize changes by complexity and create fixed review timelines for each category. Only require change notifications if they affect the device range, safety, performance, usability, and risk-benefit profile. All other changes should not require notification.
3) Introduce a dedicated and accelerated pathway for breakthrough innovations.
Key Issues: While many global regions (e.g., US, Japan, Australia) include special or fast-track pathways for innovative devices, no similar pathway is available in the EU. Further, the overall process for innovative devices in the EU is unclear and costly, making the EU a less attractive market for these device types.
Suggestions: Immediately – launch a pilot in 2025 to test out a breakthrough innovation pathway. Under MDR/IVDR legislative reform – establish the breakthrough innovation pathway based on the pilot’s results.
4) Shift to lifetime risk-based certification to reduce duplication and lower burden.
Key Issues: Re-certification is costly and time consuming. Its value is limited considering the oversight that Notified Bodies (NBs) already have via annual audits, safety reports, clinical evaluations, and post-market surveillance. And NBs already reserve the right to withdraw certificates at any time in cases of safety issues. Further, by spending time on re-certifications, NBs have less time to certify new devices, creating bottlenecks and longer times to market. Last, MedTech Europe notes the ‘unfairness’ of the current system, i.e., manufacturers that obtained MDR/IVDR certificates before the extended transitional periods are required to recertify before some legacy devices have even obtained their initial MDR certification.
NOTE: The above opinion is not shared by Team Notified Body, as noted here. Team NB proposes to maintain the 5-year certification process. However, they propose that re-certification decisions should focus on new aspects, safety aspects linked to post-market surveillance, vigilance and market surveillance, and be proportionate to the class of the risk (rather than a full repetition of the initial assessment).
Suggestions: Immediately – extend validity of MDR/IVDR certificates issued before 26 May 2024 from 5 years to 10 years. Under MDR/IVDR legislative reform – require re-certification on a risk-based basis, e.g., for novel technology or where safety issues have occurred, phase out re-certifications for safe and established technologies.
EU Open Consultations
The Commission opened two new public consultations.
Expert Panels for Orphan and Pediatric Devices: HERE
| Summary: The Commission intends to set up an expert panel in the field of orphan and paediatric devices and update administrative aspects related to the management of the panels. Expert panels provide scientific, technical and clinical opinions and advice to support implementation of the EU medical device regulations. |
| Type of Act: Implementing Decision |
| Feedback Period: 19 May 2025 – 16 June 2025 (midnight Brussels time) |
| Commission Adoption: Planned for second quarter 2025 |
Health Technology Assessments: HERE
| Summary: EU rules on health technology assessment (Regulation 2021/2282) support cooperation by EU countries to clinically assess new health technologies. The aim is to contribute to a good use of health system resources, while respecting national competences. This initiative concerns joint clinical assessments of medical devices and in vitro diagnostic medical devices. It sets out implementing rules to ensure that EU-level assessments are conducted in good time and that the relevant experts are involved or consulted. |
| Type of Act: Implementing Regulation |
| Feedback Period: 28 May 2025 – 25 June 2025 (midnight Brussels time) |
| Commission Adoption: Planned for second quarter 2025 |
Further, note that on 2 June 2025 the Commission will open the second submission period for Joint Scientific Consultations (JSCs) under the Health Technology Assessment (HTA) regulation. More information is available: HERE
“JSCs enable health technology developers to consult on the planning of their health technology clinical studies and clinical investigations of a health technology, regarding the information and evidence needed for a subsequent Joint Clinical Assessment. The submission period is open from 2 to 30 June 2025 to developers of both medicinal products and medical devices.
Developers can apply for consultation slots during this time as follows:
- Start of the procedure 29 September–2 October 2025 (Briefing document by 1 September 2025)
- Start of the procedure 27–30 October 2025 (Briefing document by 29 September 2025)
- Start of the procedure 24–27 November 2025 (Briefing document by 27 October 2025)
- Start of the procedure 12–15 January 2026 (Briefing document by 1 December 2025)
Requests must be uploaded to the HTA IT Platform by 30 June 2025. As access to the platform can take a few days, early registration is recommended.
In addition to the guidance documents for JSCs for medicinal products, the guidance documents for JSCs for medical devices and in-vitro diagnostic medical devices have also been published.”
