Below is an overview of the March 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., IMDRF revised list of Adverse Event Reporting terms, terminology, and codes, MHRA’s response to the fee increase consultation, and more.

EU Updates: MDR Specific

Call for Clarity on Pre-Submission Clinical Strategy Discussions

MedTech Europe, AESGP, MedTech & Pharma Platform, and COCIR published a joint position paper on Notified Body pre-clinical discussions: HERE

While MDCG 2019-6 provides a framework for ‘structured dialogues’ between the manufacturer and Notified Body, the paper notes this does not provide sufficient discussion in the pre-submission process. They therefore request clarification that a “pre-submission dialogue between Notified Bodies and manufacturers can include a high-level discussion of the manufacturer’s proposed clinical strategy”.

The paper outlines why this is important, and calls on the Commission and EU member states to “address this situation as a matter of priority via the foreseen implementing act for the application of uniform rules for Notified Body requirements”.

Expert Panel Feedback on Drug Eluting Stent

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

EU Updates: IVDR Specific

New Proposed IVD Common Specifications

The EU Commission published the new initiative: HERE

Summary: These common specifications for certain class D (highest risk) in vitro diagnostic medical devices set uniform and consistently high requirements for device performance across the Union. The devices covered here are those for detecting hepatitis E virus, Toxoplasma gondii, Plasmodium (malaria) and four types of arboviruses – dengue, Chikungunya, West Nile and Zika viruses, if intended to be used for testing in transfusion of blood, transplantation of tissues or organs, or for cell administration.

Type of act: Implementing regulation

Draft act: Feedback upcoming

Commission adoption: Planned for second quarter 2025

Casus’s list of Common Specifications will be updated upon adoption of the above: List of EU MDR/IVDR Harmonized Standards & Common Specifications

Second Call for EURLs

The Commission launched a second call for EU Reference Laboratories (EURLs): HERE

It will be conducted in two waves.

The first wave opens to applications in the following categories of class D devices:

The second wave opens to applications in any of the following 8 categories of Class D devices:

EU Updates: All Other

ISO 15223-1 Amendment – Authorized Representative Symbol

ISO 15223-1 ‘Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements’ has been amended: HERE

Key changes include:

1. The long-standing EC REP symbol has been updated to EU REP, reflecting the standard’s convention of using two-letter country codes (e.g., “XX REP”) to denote the authorized representative in specific jurisdictions.
2. Introduction of a new definition for “authorized representative”

“3.20
authorized representative
natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation”

Background
This was initiated by the European Commission. The MDCG Standards Working Group’s meeting from 19 January 2023 provides further context (see image below).

EN ISO 15223-1:2021 was originally harmonized under the MDR/IVDR on January 4, 2022, utilizing the EC-REP symbol to indicate ‘Authorized representative in the European Community/European Union‘.

Commission Implementing Decision C(2024)3371 (May 27, 2024) formally requests (re)harmonization of the standard.

“Moreover, for standard EN ISO 15223-1, it is necessary to include an explicit requirement on the symbol for the authorised representative in the Union, to ensure full coherence with current terminology.”

Impact on Manufacturers
There is no immediate impact to manufacturers. However, device labeling will eventually need to be updated to replace the EC-REP symbol with the EU-REP symbol, after the revised standard is harmonized under MDR/IVDR.

Manufacturers can opt to transition early. However, since the EU-REP symbol is not yet harmonized, it would need to be defined until harmonization occurs, e.g., a legend within the Instructions for Use (IFU).

MDCG Standards Working Group Meeting Minutes

The MDCG Standards Working Group 4 February 2025 meeting minutes were published: HERE

Notably, it states that six (6) new standards for the MDR and two (2) for the IVDR, will shortly be published.

Casus’s list of Harmonized Standards will be updated upon publication of the above: List of EU MDR/IVDR Harmonized Standards & Common Specifications

Team NB on Certificates with Conditions

Team Notified Body (NB) issued a press release on Certificates with Conditions: HERE

In it, they encourage Team NB members to “continually consider the possibility of issuing certificates with specific conditions, provisions, or limitations”. This is to “ensure that innovative, novel and orphan medical devices continue to be accessible to healthcare professionals and patients in the EU…”.

This mechanism allows Notified Bodies to support innovation in a controlled and safe manner. Examples of such conditions, limitations, or restrictions include:

Team NB highlights this mechanism due to a recent publication from the Co-ordinating Research and Evidence for Medical Devices (CORE-MD) titled ‘Reports on conditions on certificates by notified bodies Deliverable 3.3’. The report highlights the low-volume use of certificates with conditions by notified bodies under the Medical Device Directives, while highlighting its value to support innovation and encouraging increased use of such conditions under the MDR.

MDR/IVDR Article 10a Decision Flowchart

MedTech Europe, in collaboration with AESGP and COCIR, has developed a decision guide flowchart for MDR/IVDR Article 10a: HERE

It is based on the official text of MDR/IVDR Article 10a and the Commission’s Q&A document.

Note that Casus has a free procedure template available for download: MDR/IVDR Article 10a Procedure Template

Call to Exclude Medical Devices from ‘Trade Wars’

MedTech Europe calls on the EU to exclude medical devices from retaliatory tariffs: HERE

This includes not only finished medical devices and IVDs, but also their respective raw materials, accessories, and spare parts.

“While recognising the EU’s commitment to defending European economic interests in response to recent United States (US) trade measures, MedTech Europe deems it essential that such actions not inadvertently hinder access to life-saving medical care. From surgical procedures and emergency care to chronic disease management, uninterrupted access to medical technologies is critical for timely diagnosis, effective treatment, and patient safety. Delays or increased costs could put lives at risk, strain healthcare systems, and reduce the quality of care available to millions across Europe.”

New Consultation on EU Cybersecurity Act

The EU Commission published the new initiative: HERE

Summary: The initiative will revise the Cybersecurity Act, clarify the mandate of the EU Agency for Cybersecurity (ENISA) and improve the European Cybersecurity Certification Framework to achieve better resilience. The initiative also aims to streamline, simplify and supplement EU legislation to make the implementation of the EU cybersecurity framework more user and business friendly and to prioritise measures to support the EU objectives of developing a secure and resilient supply chain, including the EU cybersecurity industrial base.

Type of act: Proposal for a regulation

Public Consultation: Planned for 1st quarter 2025*

Commission Adoption: Planned for 4th quarter 2025

*No new update to the Commission page as of this publication.

European Health Data Space Regulation

The European Health Data Space (EHDS) Regulation went into force on 26 March 2025. The Regulation, FAQs, recorded videos, and press release are available: HERE

Background
Currently, health data is stored in different formats and systems across the EU, making cross-border healthcare difficult. Patients often face difficulties in accessing their own medical data, and healthcare professionals may not have complete information when treating patients from other EU countries.

Purpose
The EHDS Regulation establishes a common framework for accessing, using, and exchanging electronic health data, while simultaneously ensuring data protection and patient rights.

The aim is to improve the use and sharing of health data across the EU. For example:

Impact on Manufacturers
The EHDS Regulation primarily targets healthcare providers, patients, researchers, and public health authorities. However, medical device manufacturers, particularly those involved in digital health, AI-driven diagnostics, and software as a medical device (SaMD), will also be affected:

While the EHDS Regulation went into force on March 26, 2025, its immediate impact on medical device manufacturers is limited. This is due to the phased implementation timeline:

In the meantime, manufacturers could start internal assessments on the applicability of the EHDS Regulation, e.g., whether their devices claim interoperability with Electronic Health Record systems, and if so, begin familiarizing themselves with the new legislation.

NoBoCap C-Level Training

NoBoCap (Notified Body Increased Capacity) is co-funded under the EU4Health programme. They aim to increase the number of qualified personnel within Notified Bodies, and ensure faster, more efficient conformity assessments for medical devices.

As part of the above initiative, NoBoCap is organizing a series of trainings, including sessions designed for MedTech C-level executives: HERE

Registration is now open, and the training begins May 16, 2025. The course agenda is available: HERE

“We will guide you through the necessary steps, timelines, resources, and budgets needed for efficient product development—including pre-clinical and clinical testing—quality management system (QMS) setup, and the creation of high-quality technical documentation for Notified Body assessment. This session also emphasizes that MDR/IVDR compliance requires involvement across the entire organization, with dedicated roles, functions, and competencies. Additional key issues relevant to efficiently and strategically marketing your product in Europe will also be addressed.”

UK Updates

Team AB IVD Working Group

Team Approved Body (Team-AB) announced the “inaugural kick-off meeting” of its new IVD Working Group: HERE

“The recent MHRA consultation (and in particular the proposed International Reliance conformity routes and changes to the classification of IVDs under UKCA) were on the agenda, as was the recent MDCG 2020-16 rev 4 announcement of the EU downgrading of COVID-19 from a Class D to a Class-B device (with COVID self-tests being class C).

This meeting marked an important move to give IVDs their voice within Team-AB, and will hopefully result in better alignment and closer working ties between approved bodies and with the MHRA and industry-led groups such as BIVDA.”

MHRA Exceptional Use Authorisation Guidance

The MHRA published new guidance on how to apply for exceptional use authorization (EUA) in the UK: HERE

This mechanism allows non-UKCA/CE marked devices to be placed on the UK market “when doing so is in the interest of the protection of public health”. Manufacturers must be able to justify that the EUA is needed to fulfill an immediate patient or public health need, or to prevent disruptions in patient care.

CFS for IVDs for Performance Evaluation

The MHRA updated its Certificate of Free Sales Reference Guide: HERE

It was revised to clarify that a Certificate of Free Sale (CFS) cannot be ordered for IVDs for performance evaluation.

GMDN Training for GMDN Members

The GMDN’s March newsletter includes details for a training opportunity: HERE