On 5 May 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/977 — a regulation that directly changes how notified bodies handle conformity assessments under the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).

If you’re a medical device or IVD manufacturer working toward CE Marking, this affects your timeline, your budget planning, and how you deal with your notified body.

The European Commission has published Commission Implementing Regulation (EU) 2026/977 to improve consistency among MDR and IVDR Notified Bodies.

For years, manufacturers have faced challenges such as:

• Long certification timelines
• Different approaches between Notified Bodies
• Unexpected costs
• Delays in recertification

The new regulation introduces clearer rules for Notified Bodies, helping manufacturers better predict timelines, costs, and recertification activities.

While the regulation is directed at Notified Bodies, manufacturers will benefit from greater transparency and more predictable certification processes.

Commission Implementing Regulation (EU) 2026/977 was introduced to create a more consistent and predictable approach among MDR and IVDR Notified Bodies across Europe.

Until now, manufacturers often experienced significant differences in how Notified Bodies handled:

• Certification reviews
• Technical Documentation assessments
• Quality Management System (QMS) audits
• Reviews of substantial changes
• Recertification activities

As a result, some manufacturers received clear timelines and quotations, while others faced long delays, inconsistent review processes, and unexpected costs. Small and medium-sized manufacturers were particularly affected by these uncertainties.

The new regulation establishes common operational rules that all MDR and IVDR Notified Bodies must follow, helping to improve consistency throughout the certification process.

Key Objectives of the Regulation

More predictable certification timelines

• Greater transparency regarding fees and costs
• Consistent review processes across Notified Bodies
• Improved planning for certification and recertification activities
• Reduced administrative uncertainty for manufacturers

By standardizing the way Notified Bodies operate, the European Commission aims to make MDR and IVDR certification more efficient, transparent, and easier for manufacturers to plan and manage.

For the first time, the European Commission has defined maximum timelines that Notified Bodies should follow (Initial MDR/IVDR Certification Timeline)

Many manufacturers are approaching MDR and IVDR certificate renewal.

The new regulation clearly defines what information must be submitted during recertification.

Manufacturers Should Prepare:

• Summary of all device changes
• Latest PSUR (where applicable)
• Field Safety Corrective Action summary
• Updated Risk Management information
• Latest Clinical Evaluation Report (CER)
• Latest Performance Evaluation Report (PER) for IVDs
• Evidence of compliance with new standards and Common Specifications

Notified Bodies must also evaluate:

• New regulatory requirements
• New scientific evidence
• State-of-the-art developments
• Updated harmonized standards

To benefit from the new regulation, manufacturers should:

1. Maintain up-to-date technical documentation.
2. Keep Clinical Evaluation Reports and Performance Evaluation Reports current.
3. Track all device changes and design modifications.
4. Maintain robust PMS and vigilance records.
5. Start recertification planning at least 12–18 months before certificate expiry.
6. Engage experienced MDR and IVDR consultants early to identify documentation gaps.

Regulation (EU) 2026/977 is designed to make MDR and IVDR certification more predictable and transparent.

Although the regulation primarily targets Notified Bodies, manufacturers will benefit from clearer timelines, structured recertification requirements, and improved visibility into certification costs and performance.

Companies that proactively maintain compliant technical documentation and begin recertification planning early will be best positioned to avoid certification delays and maintain uninterrupted access to the European market.

Information sourced from EUR-Lex – Access to European Union law