European Commission’s proposal to amend the MDR and IVDR

Background

Since the MDR and IVDR entered into force (2021 and 2022, respectively), manufacturers have faced significant challenges, including certification bottlenecks, inconsistent interpretation across EU Member States, and disproportionate compliance costs. Repeated extensions of transitional periods helped avoid device shortages, but they did not solve the underlying structural issues.

The European Commission’s targeted evaluation found that these problems are now affecting:

• Availability of devices, especially niche and innovative products.
• Competitiveness of EU manufacturers, particularly SMEs.
• Speed of innovation, with some products delayed or withdrawn from the EU market.

This new proposal aims to fix these issues while maintaining Europe’s high standards of health and safety.

What is changing

Here is an overview of some of the key proposed changes:

1.  A more simplified and proportionate framework

• Person Responsible for Regulatory Compliance (PRRC). The Commission proposes removing the detailed qualification requirements for the PRRC, as well as the obligation for SMEs, which rely on an external PRRC, to have the PRRC “permanently and continuously” available.
• Certificates and recertification. The fixed five-year validity of certificates would be abolished. Instead, notified bodies would conduct risk-based periodic reviews, avoiding unnecessary full recertifications.
• Clinical evidence requirements. A wider range of data may qualify as clinical data. The conditions for relying on clinical data of equivalent devices are also made more flexible. The possibility to demonstrate a device’s safety and performance based on non-clinical alone (including performance evaluation, bench testing, in vitro, ex vivo, in silico testing, computational modelling or simulation and pre-clinical evaluation) is expanded.
• Classification. Some classification rules are adapted resulting in lower risk classes for certain devices, such as reusable surgical instruments, accessories to active implantable devices and software (New Rule 11 in Annex VIII of the MDR with wider possibility for software to be regulated as Class I).
• AI Act: Most of the requirements applicable to high risk AI systems under the EU AI Act would not be applicable to medical devices manufacturers.

2.  Reduced administrative burden

• Summaries of Safety and Clinical Performance (SSCP/SSP). These would be required only for devices subject to full technical documentation assessment, and no longer require separate validation by notified bodies.
• Post-market obligations. The frequency according to which manufacturers are obliged to update periodic safety update reports (PSUR) is reduced and manufacturers will have 30 days (instead of the current 15 days) for reporting serious incidents.
• Changes after certification. Clearer rules would distinguish which changes require notification, approval, or no action, including the possibility of agreed change control plans.
• Authorisation/notification of certain performance studies. Performance studies involving only routine blood draws will not be subject to prior authorisation. The notification of performance studies on companion diagnostics using left-over specimen will be removed.
• Audits. Greater use of remote audits, less frequent surveillance audits where justified, unannounced audits limited to “for-cause” situations.
• Digitalisation: EU Declaration of Conformity may be provided in digital form. Manufacturers may also provide electronic IFUs (eIFU) for near-patient tests.

3.  Supporting innovation and access to devices

• Breakthrough and orphan devices. Criteria for breakthrough devices and orphan devices are introduced. After ‘designation’ by an expert panel, breakthrough devices and orphan devices will be subject to a priority and rolling review. Orphan devices that were CE marked under the former Directives may continue to be placed on the market beyond the transitional periods, subject to conditions.
• In-house devices. The conditions for manufacturing and using in-house devices in health institutions would be made more flexible, particularly under the IVDR (e.g., the condition that there is no equivalent device on the market is removed). Central laboratories manufacturing and using tests exclusively for clinical trials are added to the scope of the in-house device exemption.
• Reprocessing of single use devices. Manufacturers will be required to provide a justification for single use claims in their devices’ technical documentation.
• Structured dialogue. A legal basis for notified bodies and manufacturers to conduct pre- and post-submission structured dialogues based on documented procedures will be introduced.
• Clinical evaluation (CECP) and performance evaluation (PECP) consultation procedure. The scope of the CECP will be limited to class III implantable devices and the PECP will be removed. Instead, the possibility of early advice from expert panels for class C and D IVDs will be introduced.
• Combined studies (involving medicinal products, medical devices and/or IVDs). For a combined study, the sponsor may submit a single application, triggering a coordinated assessment (the Clinical Trials Regulation will be amended accordingly).
• Notified body fees for conformity assessment: Notified bodies will be required to apply at least a 50% fee reduction for manufacturers that are micro enterprises within the meaning of Recommendation 2003/361/EC and at least a 25% fee reduction for small enterprises within the meaning of that Recommendation. They will be required to apply at least a 50% fee reduction for manufacturers that apply for conformity assessment of an orphan device. Manufacturers that are micro or small enterprises will have the possibility to defer the payment of fees until the relevant conformity assessment activity is finalised.

4.  Stronger coordination and governance

• Borderline and classification decisions. The coordination among competent authorities regarding the qualification of a product and the classification of a device (‘Helsinki procedure’) will be codified, with the possibility to request opinions from expert panels. Classification decisions will be taken within 90 days unless substantiated disagreement has been raised by a Member States and an expert panel opinion is necessary.
• Dispute resolution. National authorities responsible for notified bodies would act as ombudspersons in disputes between manufacturers and notified bodies. Disputes should be handled by these authorities within 90 days.
• Expanded role of expert panels. Expert panels would move beyond their current, narrow review function and provide scientific, technical and regulatory advice across the system, including on classification issues, innovative devices and crisis situations.

What happens next?

The proposal will now be examined by the European Parliament and the Council under the ordinary legislative procedure and changes are still possible.

Authored by Fabien Roy