The European Commission announced today (16 December) its plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices (“IVDs”).  Many industry stakeholders have criticized the current EU device rules as being slow, costly, unpredictable, and unnecessarily complex. Under the proposed revisions, the Commission aims to make the rules “easier, faster and more effective and further promote competitiveness, innovation and a high-level of patient safety.”

The proposal includes a new regulation (“Proposed Regulation”) to amend certain provisions under the EU Medical Devices Regulation (EU) 2017/745 (“MDR”) and IVD Regulation (EU) 2017/746 (“IVDR”) (among other legislation), which govern device regulations across the EU.  The Proposed Regulation marks a significant, but early, step in the legislative process.  At this stage it is simply a proposal.  It will need to be considered by the European Parliament and the Council, and will only take effect if formally adopted – likely with revisions.  As a result, we do not anticipate that any changes will come into force until at least the end of 2026, depending on the speed of the legislative process. 

That said, the Proposed Regulation includes various proposals that may be significant for medical device manufacturers, as well as the device and diagnostics industry more broadly.  We highlight the key proposed amendments below, and will provide further detail on specific aspects of the Proposed Regulation in future blogs as we continue to digest its content and impact.

• Amendment to classification rules for MDSW. Rule 11 of the classification rules in Annex VIII of the MDR relating to medical device software (“MDSW”) will be amended, potentially allowing a broader range of MDSW to fall under a Class I classification and therefore not require a Notified Body assessment.  This change could also impact the relevance of the EU AI Act to AI MDSW and potentially reduce the number of AI MDSW deemed “high risk” under the AI Act.

• Reduction in re-certification requirements. Devices that undergo assessment by a Notified Body currently require re-certification at least every five years. The Proposed Regulation would remove the current five-year cap on the validity of Notified Body certificates of conformity.

• Expanding the use of eIFUs. Currently, IVDs (other than software IVDs) may only use electronic instructions for use (“eIFUs”) instead of paper-based versions where the IVD does not involve near-patient testing and is intended for professional use. Under the Proposed Regulation, professional use IVDs for near-patient testing may also use eIFUs.

• International reliance and cooperation. The Proposed Regulation lays the groundwork for global regulatory convergence by promoting international cooperation, such as through the EU’s participation in the Medical Device Single Audit Program (“MDSAP”).  This is an international initiative that allows a single regulatory audit of a manufacturer’s quality management system to satisfy the requirements of multiple jurisdictions.  Current jurisdictions that recognise MDSAP audits are the U.S., Australia, Brazil, Canada and Japan.

• Expansion of the provisions for in-house devices.Articles 5(5) of the MDR and IVDR, respectively, provide specific rules for devices/IVDs that are manufactured and used only in EU health institutions.  These rules essentially provide an exemption to CE marking, subject to the satisfaction of several conditions, including that the devices/IVDs cannot be transferred from the health institution.  The Proposed Regulation seeks to make the conditions more flexible, such as by permitting the transfer of such in-house devices if this is in the interest of patient safety or public health, or to prepare for or respond to a public health emergency.  Further, with respect to the IVDR, the Proposed Regulation provides for the removal of the condition that there be no equivalent device on the market that could appropriately meet the target patient group’s particular needs.

• Regulatory sandboxes. Under the Proposed Regulation, the European Commission and Members States will have the ability to establish “regulatory sandboxes” to target emerging technologies, subject to the oversight of a relevant Member State competent authority.  The Proposed Regulation defines a “regulatory sandbox” as:

“a controlled environment set up by a competent authority which offers manufacturers or prospective manufacturers the possibility to develop, test, validate and use, where appropriate in real-world conditions, an innovative product or technology potentially falling within the scope of this Regulation, pursuant to a sandbox plan for a limited time under regulatory supervision.”

• New special pathways for orphan and breakthrough innovations. The Proposed Regulation introduces new criteria for conformity assessments for breakthrough devices and orphan devices. 
  • Devices are considered “breakthrough” if they are expected to introduce “a high degree of novelty” and “a significant positive clinical impact on patients or public health, for a life-threatening or irreversibly debilitating disease or condition.”
  • Devices will be treated as “orphan devices” if they (a) are intended for the treatment, diagnosis, or prevention of a disease or condition that presents in not more than 12,000 individuals in the EU per year; and (b) at least one of the following criteria is met: (i) there are insufficient available alternatives, or (ii) the device is expected to provide a clinical benefit compared to available alternatives or the state of the art, taking into account both device-specific factors and patient population-specific factors.
  • Where medical devices/IVDs meet the above criteria – as determined by an expert panel – the Proposed Regulation provides that Notified Bodies must prioritize their conformity assessments and, where appropriate, apply a rolling review to compress assessment timelines.
  • The Proposed Regulation also envisages that manufacturers of such devices/IVDs would have access to advice on their clinical/performance evaluation strategies from an expert panel.

• Improved clinical investigation procedures.  The Proposed Regulation seeks to amend the MDR and IVDR to simplify the requirements applicable to clinical investigations of medical devices and performance studies of IVDs where appropriate to do so considering the risks to the study subjects.  For instance:
  • Notably, the Proposed Regulation seeks to streamline the conduct of combined studies involving both medicinal products and medical devices/IVDs.  In such combined studies, the Proposed Regulation provides that the sponsor may submit a single application for authorization, triggering a coordinated assessment, in accordance with Regulation (EU) No 536/2014 on clinical trials (as it is set to be amended under the proposed EU Biotech Act (see our separate blog posts on the EU Biotech Act proposals).
  • With respect to IVDs only, the Proposed Regulation will amend the IVDR so that (i) performance studies involving only routine blood draws will not require prior authorization, and (ii) the notification requirements related to performance studies on companion diagnostics using leftover specimens will be removed.

Separate from the Proposed Regulation, the Commission also recently published a draft Commission Implementing Regulation on quality management and procedural requirements for Notified Body conformity assessment activities.  This aims to introduce uniform rules for Notified Body assessments, including with respect to costs, timelines and transparency of processes.

Please note that this blog is based on the wording of the EU’s proposal published on 16 December 2025.  This wording could significantly change during the legislative process. Our European Life Sciences and MedTech team will continue to monitor this legislation.  Please feel free to reach out to the team with any questions and please keep an eye out for our future updates.