MedTech Europe Supports MDR and IVDR Simplification Proposal Focused on More Proportionate Lifecycle Oversight

MedTech Europe has published the document MDR/IVDR simplification proposal provides a more proportionate approach to life cycle oversight, in which it analyses the European Commission’s proposal to amend the MDR and IVDR. According to the association, the proposal could reduce administrative burdens while improving the efficiency and sustainability of the European regulatory system.

According to MedTech Europe, the proposal represents an opportunity to make regulatory oversight more focused on actual risks while maintaining current levels of public health protection and patient safety.

A More Risk-Based Approach

MedTech Europe considers that the European Commission’s proposal introduces a more proportionate and risk-based approach to oversight and assessment activities throughout the device lifecycle.

According to the document, the revision seeks to replace duplicative administrative processes with more targeted mechanisms, potentially freeing up capacity for Notified Bodies and competent authorities to focus on areas with the greatest impact on safety.

The elements highlighted include:

• Periodic certificate reviews in place of certain recertification cycles;

• Continuous annual surveillance;

• Assessment of significant device changes before implementation;

• Continuous updates of safety and performance information;

• Targeted technical documentation reviews;

• Assessment of representative devices.

Increased Focus on Safety Signals

MedTech Europe argues that the proposed simplification could free up resources currently devoted to repetitive administrative activities.

According to the association, this approach could allow greater focus on the analysis of:

• Post-market surveillance data;

• Safety signals;

• Incident trends;

• Devices presenting specific compliance concerns.

The document states that more targeted oversight may support earlier detection of safety issues and more timely interventions when necessary.

Greater Flexibility for Notified Bodies and Authorities

The document also highlights greater flexibility in audit and oversight activities.

Measures mentioned include:

• Risk-based audits;

• Targeted unannounced audits;

• Use of remote audits;

• Greater use of EUDAMED to support transparency and regulatory oversight;

• Better integration of post-market surveillance data.

According to the association, these measures could contribute to a more efficient use of available resources without compromising regulatory oversight.

Fundamental MDR and IVDR Principles Remain Unchanged

MedTech Europe emphasises that the proposal does not alter the fundamental principles of the lifecycle oversight system introduced by the MDR and IVDR.

According to the document:

• Manufacturers remain responsible for the safety and performance of devices throughout their lifecycle;

• Notified Bodies retain their role in conformity assessment and surveillance;

• Competent authorities remain responsible for market surveillance, oversight and enforcement activities.

The association also highlights that tools such as UDI and EUDAMED continue to support device traceability and transparency within the European market.

Relevance for Medical Device and IVD Manufacturers

The document is particularly relevant for medical device and IVD manufacturers, as it addresses changes that could directly influence regulatory compliance activities and post-market oversight.

Topics of particular interest include:

• Simplification of MDR and IVDR requirements;

• Risk-based oversight;

• Post-market surveillance;

• Notified Body activities;

• Technical documentation review;

• Regulatory process efficiency.

According to MedTech Europe, the proposal aims to reduce administrative activities considered duplicative while maintaining the control mechanisms necessary to ensure device safety and performance.