The European regulatory landscape for medical devices and IVDs continues to evolve. In December 2025, the European Commission published a proposal to simplify selected elements of the MDR and IVDR, while preserving patient safety and regulatory oversight. At the same time, EUDAMED is moving from preparation to mandatory use, with clear deadlines set for 2026.

• For manufacturers supplying the EU market, this creates a familiar challenge: regulatory change is unavoidable, but disruption is not. Organisations that prepare early can maintain market continuity, avoid last-minute remediation, and reduce compliance risk.

What is changing (at a glance)

MDR/IVDR: targeted simplification under discussion

The Commission’s proposal signals a clear intention to reduce unnecessary administrative burden and address known bottlenecks in the regulatory system. While the proposal is not yet law, it reflects strong regulatory momentum to stabilise the European market and prevent further loss of medical devices and IVDs.

• For manufacturers, the key message is reassurance: regulators recognise the pressure on the system and are acting to improve it.

EU Authorised Representative (EAR) role: more flexibility, clearer collaboration

The proposal also touches on the role of the European Authorised Representative (EAR). The direction of travel is toward greater contractual flexibility, allowing manufacturers and EARs to agree on additional support activities where appropriate. This is positive news for non-EU manufacturers, as it enables a more integrated compliance model. At the same time, it reinforces the importance of working with an EAR that operates under a robust quality system, with clearly defined roles and responsibilities.

• Business benefit: a well-structured EAR partnership can move beyond “formal representation” and become a practical extension of the manufacturer’s regulatory organisation.

EUDAMED: mandatory use from May 2026

EUDAMED is no longer a future concept, it is becoming a regulatory reality.

Following the European Commission’s functionality notice published on 27 November 2025, mandatory use of the first four EUDAMED modules will apply from 28 May 2026:

• Actor Registration
• UDI and Device Registration
• Notified Bodies and Certificates
• Market Surveillance

This milestone applies regardless of any future MDR/IVDR amendments. This means in practice:

• Compliance will depend not only on registering data, but on maintaining accurate, controlled, and auditable information over time. Organisations that treat EUDAMED as a one-off registration exercise risk operational gaps and regulatory exposure.

Increased focus on Post-Market Surveillance (PMS) and lifecycle control

Recent guidance and policy discussions confirm a continued shift toward stronger post-market surveillance (PMS), vigilance, and lifecycle oversight. Rather than adding unnecessary complexity, the intent is to ensure that real-world performance and safety data are systematically collected and acted upon.

• For manufacturers, this trend reinforces the value of:
  • scalable PMS processes,
  • structured complaint and vigilance workflows, and
  • clear interfaces between regulatory, quality, and operational teams.

How manufacturers can prepare – without over-investing

Based on current developments, several “no-regret” actions make sound business sense:

Establish EUDAMED readiness early

• Define ownership of EUDAMED data, align internal stakeholders, and ensure device and certificate information is maintained consistently over time.

Strengthen your EAR collaboration model

• Review your AR agreement to ensure clarity of scope, accountability, and escalation pathways. A strong AR relationship reduces friction with authorities and supports continuity during audits, inspections, and market surveillance activities.

Align PMS with operational reality

• Ensure that PMS and vigilance are integrated into daily operations, not treated as theoretical or purely regulatory exercises.

How QNET supports manufacturers

• QNET works with international medical device and IVD manufacturers as a long-term regulatory partner, providing:
  • EU Authorised Representative (EAR) services under a compliant ISO 13485 quality management system
  • Practical EUDAMED readiness and data governance support
  • PMS and vigilance framework design and implementation
  • Strategic regulatory guidance across the EU, UK, and Switzerland

Our approach is pragmatic, risk-based, and designed to support business continuity, not just regulatory compliance.

Looking ahead

• While the MDR/IVDR proposal continues through the legislative process, EUDAMED deadlines are already fixed. Manufacturers that act early will be better positioned to adapt smoothly, avoid compliance surprises, and maintain uninterrupted access to the European market.
• Regulatory change does not have to slow your business if it is managed proactively.

Call to action

• Would you like to assess your EUDAMED and MDR/IVDR readiness for 2026?
  QNET can support you with a focused, practical review tailored to your product portfolio and market strategy.