Below is an overview of the February 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., the EU draft amendment to eIFU legislation, MDCG 2019-6 revised to clarify ‘structured dialogues’ with Notified Bodies, and more.

European Union

MDCG 2025 List of Ongoing/Planned Guidance

The list is available: HERE

As noted in the PDF document, this “reflects the MDCG subgroups’ Annual Work Programmes but it is not an exhaustive list of ongoing work performed by MDCG Subgroups”.

Below we provide some of the notable items planned for 2025.  

Scope	Group Deliverables	Planned MDCG Endorsement
Clinical Investigations and Evaluation (CIE)
MDR	Clinical investigation – Q&A document	Q3 2025
MDR	Update of the clinical evaluation guidance	Q3 2025
MDR	Update of the MDCG 2019-9 – Rev.1 Summary of safety and clinical performance	Q2 2025
Post-Market Surveillance and Vigilance (PMSV)
MDR + IVDR	Update MIR form, MIR PDF file, MIR Help text and related documents	Q1 2025
MDR + IVDR	Revision of MIR Q&A document	Q2 2025
MDR + IVDR	Revision of Field Safety Corrective Action form	Q2 2025
IVDR	Extension of PSUR guidance IVDR	Q1 2025
MDR + IVDR	Guidance on Post-Market Surveillance	Q4 2025
MDR	MDR Vigilance guidance on implementation of Articles 87 and 89 MDR	Q4 2025
MDR + IVDR	Revision of Trend report and related documents	Q2 2025
Borderline & Classification (B&C)
MDR	Minor revision of classification guidance MDCG 2021-24	Q3 2025
New Technologies
MDR + IVDR	Legal status of app providers	Q2 2025
MDR + IVDR	Targeted revision of MDCG 2019-11 (Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746)	Q1 2025
MDR + IVDR	FAQ on Interplay between MDR/IVDR and AI Act	Q2 2025
In Vitro Diagnostic Medical Devices (IVD)
IVDR	Questions and Answers document on performance studies	2025
IVDR	Guidance on Research Use Only devices	2025
IVDR	Q&A guidance on distance sales	2025
Nomenclature
MDR + IVDR	Tool for EMDN definitions	2025

Reminder of MDR/IVDR Targeted Evaluation

Swiss Medtech published a reminder to industry, to provide feedback on the targeted evaluation of the MDR/IVDR: HERE

There is less than one month to provide feedback. The link to do so is available: HERE

MDCG EUDAMED Working Group Meeting Minutes

The MDCG EUDAMED working group published the minutes from the 4 December 2024 meeting: HERE

Some items of note include:

• The audit of the first 4 modules (Actor, UDI/Device, NBs & Certificates and Market Surveillance) is progressing well.
• The audit on Vigilance will be slightly postponed, however such delay should not affect the timeline for its mandatory use.
• The Commission confirmed that EUDAMED will notify EU Authorized Representatives when their manufacturers register devices in the UDI/Devices module.
• The development of the clinical investigation/performance study module is on hold and expects to resume the activity in the coming months.
• Regarding the webinars to train users, the Commission underlined that it is putting in place an onboarding strategy that includes training and webinars (including face-to-face events).

MDCG Main Working Group Meeting Minutes

The minutes from the 17-18 December 2024 MDCG meetings are available: HERE (without stakeholders) and HERE (with stakeholders)

Some items of note include:

• The second call for EU Reference Laboratories (EURLs) for the additional two scopes will be delayed until early 2025, to allow for further discussion with the MDCG regarding the capacity and expertise of current EURLs.
• The creation of a dedicated task force on innovation and breakthrough devices will be circulated after the meeting, together with the call for expression of interest for participation from nominated representatives from Competent Authorities (CAs).
• The first meeting for the ad-hoc task force to address issues of practical application (with a view to resolve issues of divergent interpretation to reduce administrative burden and to harmonize Notified Body conformity assessment activities) will take place mid-January 2025.
• MDCG members have been invited to respond to a survey relevant to phasing out animal testing.

Expert Panel Feedback on Bioabsorbable Mesh

The Expert Panel’s decision and opinion under the Clinical Evaluation Consultation Procedure is available: HERE

Pilot Coordinated Assessment Process (CIP)

The overview is available: HERE

The pilot coordinated assessment allows sponsors of qualifying clinical investigations and performance studies to submit a single application for a coordinated assessment, rather than applying separately to each individual national competent authority. It ultimately aims to:

• Simplify the approval process, as a single coordinated assessment is conducted for multiple Member States instead of separate national reviews.
• Harmonize requirements, ensuring a more consistent approach to clinical investigation approvals across different EU countries.
• Reduce costs and time, minimizing duplication of work and making clinical investigations more efficient for sponsors.
• Enable early engagement with authorities, allowing sponsors to engage in pre-submission discussions with regulators, improving their chances of a smoother approval.

Sponsors interested in participating in the EU pilot coordinated assessment should complete the expression of interest form and email it to [email protected] by Monday, June 30, 2025. Use ‘Expression of Interest for Coordinated Assessment Pilot’ as the subject line of your email.

The call for in vitro diagnostic (IVD) devices will be opened at a later stage.

HTA Joint Scientific Consultations

The Commission launched the first request submission period for Joint Scientific Consultations (JSCs) under the Health Technology Assessment (HTA) Regulation: HERE

JSCs are a collaborative process that allows health technology developers to obtain scientific consultation during the planning of clinical investigations from multiple Health Technology Assessment bodies, reducing duplication of efforts.

The period that allows for medical devices is open between Monday, June 2, 2025 – Monday, June 30, 2025.

Instructions for submitting JSC requests are available: HERE

Draft Implementing Act on NBs

The Commission is preparing a new implementing regulation on Notified Bodies: HERE

The aim is to ensure that the 50 (and counting) Notified Bodies operate on the basis of uniform criteria across the EU, thereby reducing differences in regulatory interpretation.

Summary: The proposed initiative would lay down rules for applying the requirements to be met by ‘notified bodies’ – the independent bodies tasked with assessing and certifying medical devices and in vitro diagnostics. These bodies are designated and regularly monitored by the relevant national authorities.

Type of act: Implementing regulation

Draft act: Feedback – Upcoming

Commission adoption: Planned for – Fourth quarter 2025

Note the joint statement published by MedTech Europe, regarding this implementing act.

Possible Procurement Restriction of Devices from China

The Commission is considering restricting Chinese manufacturers from bidding on EU government contracts: HERE

The Commission’s report confirmed the existence of a “Buy China” policy in its public procurement of medical devices, favoring domestic products over imported ones. This policy is implemented through various measures, including legal and regulatory frameworks, and is reinforced by national plans and industry promotion efforts. The Commission found that these measures create a discriminatory environment for foreign medical device companies and restrict their access to the Chinese market. Additionally, the investigation revealed a lack of transparency in Chinese procurement procedures.

Due to this, the Commission advised:

“The EU remains committed to engaging China in a constructive dialogue aimed at addressing and eliminating the discriminatory measures. However, in the absence of an acceptable solution, the Commission will now carefully assess the possibility of adopting IPI [International Procurement Instrument] measures. If it finds that such measures are in the EU interest, they could include a restriction on, or exclusion of, Chinese bidders of government contracts in the EU.”

United Kingdom

Legacy CE Marked Devices

The MHRA published new guidance webpages: HERE (medical devices) and HERE (IVDs)

The new IVD legacy device guidance webpage:

• Formally recognizes the extended transition period for IVDD CE marked legacy devices
• Provides a template IVDR Art. 110 extension confirmation template
  • Either this template or the Notified Body confirmation letter (if available) must be provided in the MHRA registration application

The medical device legacy guidance was formerly available as a PDF document. It is now:

• Provided as a webpage instead, and
• Introduces a minor change, allowing either the Notified Body confirmation letter or the MDR Art. 120 confirmation template to be provided in the MHRA registration application.

New MHRA Blog Post

The MHRA published a new entry in its blog: HERE

Some items of note include:

• Laura Squire’s recent departure as the MHRA’s Chief Healthcare Quality and Access Officer
• Department for Science, Innovation and Technology launched the AI Opportunities Action plan, which sets the challenge for regulators to really understand AI before regulating it, and thereby help ensure regulations are proportionate and based on science.
• On 28 January 2025 the MHRA held its first Guidance Working Group. This is a new stakeholder group that will support the drafting of medical device regulatory guidance documents for all the new regulations.
• The MHRA received nearly 300 responses to their recent open consultation and are now analyzing the responses and “using them to refine our draft regulations, to stay on track with our Roadmap and notify the new regulations to the World Trade Organization this Spring.”

MHRA Consultation Response (Partial)

The MHRA published a partial response to its recent open consultation: HERE

It addresses the MHRA’s proposal to maintain the following EU legislation within the UK MDR 2002:

• Commission Decision 2002/364 on the common specifications for in vitro diagnostic medical devices
• Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
• Regulation (EU) No 722/2012 concerning particular requirements for medical devices manufactured utilizing tissues of animal origin
• Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies

These were otherwise set to expire in Great Britain on 26 May 2025 (their “sunset date”).

“…the government intends to amend the Medical Devices Regulations 2002 to revoke the sunset date…

“…the government will draft and make the necessary secondary legislation as soon as Parliamentary time allows.”

Regarding the eIFU Regulation:

“In response to comments received about electronic instructions for use and common technical specifications, as mentioned in the introduction to this document, the MHRA is currently developing ‘Pre-Market’ legislation that will make a series of updates to the Medical Devices Regulations 2002 to improve patient safety. That legislation will not make any changes to Regulation (EU) No 722/2012 or 920/2013, however it will replace the reference in domestic law to Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices with the more up to date Implementing Regulation (EU) 2021/2226.”

Types of Marks by Product Type

The UK published a table of marks allowed in Great Britain (GB: England, Scotland, Wales), based on product type: HERE

Some examples are provided below. Please click the above link for the full list.

Product type	Marking required to place product on GB market	Department owning legislation
Batteries	None in GB, CE in NI	Defra
Electrical equipment	UKCA or CE	DBT
Electromagnetic compatibility	UKCA or CE	DBT
Machinery	UKCA or CE	DBT
Medical devices	UKCA or CE	MHRA
PPE (personal protective equipment)	UKCA or CE	DBT
Radio equipment	UKCA or CE	DBT
Restriction of hazardous substances in electrical and electronic equipment	UKCA or CE	Defra

Digital Mental Health Technologies

The MHRA published new guidance for manufacturers of digital mental health technologies: HERE

The new guidance explains:

• How to define and communicate the intended purpose of a digital mental health technology.
• When a digital mental health technology product is considered a medical device under UK law.
• How risk classification is determined, ensuring proportionate regulation for different types of technologies.

As noted by the MHRA:

“Digital mental health technologies (DMHT) are software and digital products that support mental health and wellbeing. They can be websites, internet-based platforms or applications (apps) to be used with non-medical technology, such as computers, mobile phones, fitness wearables, and virtual reality (VR) headsets, or medical technology, such as transcranial direct current stimulation (tDCS) headsets. They can be available as direct-to-consumer products intended for patients and the public or used with a referral or supervision from healthcare or educational professionals, as part of the blended delivery of mental health care.

Some DMHT qualify as medical devices and therefore need to be regulated as such to ensure effectiveness, reliability and acceptable safety.”

Note: the original guidance was published 3 February 2025 and a revision published on 13 February 2025. The revision included changes to the wording of Example 6 and Example 14.

Switzerland

Post-Market Surveillance Inspection Results

Swissmedic published results from its inspection of the Post-Market Surveillance (PMS) documentation of 30 legacy devices: HERE

All devices were Class IIa or higher. 28 of the 30 products were from foreign manufacturers, in which case the Swiss Authorized Representative was the point of contact.

Non-conformities were raised for 20 out of the 30 devices, for a total of 85 non-conformities.

• For 11 products there was no post-market surveillance plan, or the post-market surveillance plan did not fulfil the requirements (Figure 3).
• For 8 products the safety report was not prepared according to the post-market surveillance plan (Figure 4).
• For 9 products the information that needs to be included in the safety report for the entire device lifetime was missing or incomplete.

Below Swissmedic highlights the ongoing focus on PMS conformance, and the increased market surveillance of manufacturers (and their authorized representatives).

“In the interest of patient health and safety, Swissmedic urges all manufacturers to review their post-market surveillance processes and documentation and ensure the requirements of the MedDO are fulfilled. Adequate post-market surveillance processes are fundamental to the early detection and resolution of potential problems related to the use of medical devices. Swiss authorised representatives are encouraged to inform the manufacturers with which they have mandates of the results of this focus campaign.”