Regulation (EU) 2026/977 Establishes New Rules for Notified Bodies on Timelines, Costs, and Procedures

The European Commission (EC) has published Regulation (EU) 2026/977, introducing a harmonized framework of quality and procedural requirements for the activities of Notified Bodies (NBs) under the European medical device regulatory system.

The new Implementing Regulation aims to reduce operational differences between Notified Bodies, improve consistency in conformity assessment activities, and increase predictability for manufacturers regarding timelines, costs, and certification procedures.

The publication was further highlighted in the European Commission eNEWS article titled “Medical Devices: New Implementing Regulation sets out uniform requirements for conformity assessment and notified bodies”, published on 18 May 2026.

Purpose of Regulation (EU) 2026/977

Over recent years, manufacturers have experienced significant variability among Notified Bodies regarding:

• Conformity assessment timelines

• Technical documentation review expectations

• Audit duration and scheduling

• Cost structures

• Communication practices

• Certificate issuance timelines

These inconsistencies have created uncertainty for manufacturers attempting to plan regulatory submissions, product launches, and market access strategies under the EU MDR and IVDR frameworks.

Regulation (EU) 2026/977 was introduced to create a more harmonized and transparent system across all designated Notified Bodies.

Key Objectives of the Regulation

The regulation focuses on three major areas:

1. Harmonization of Procedures

The Implementing Regulation establishes standardized procedural requirements for conformity assessment activities performed by Notified Bodies.

This is intended to reduce variability between organizations and create a more consistent experience for manufacturers across Europe.

2. Improved Predictability of Timelines

One of the most significant aspects of the regulation is the introduction of expected maximum timelines for major conformity assessment activities.

The regulation establishes the following maximum timelines:

• Maximum 30 days for conformity assessment application review

• Maximum 120 days for Quality Management System (QMS) audit activities

• Maximum 90 days for Technical Documentation Assessment (TDA)

• Maximum 20 days for certification decision and issuance of certificates, including EUDAMED registration

These timelines are expected to improve planning capabilities for manufacturers and reduce uncertainty during certification projects.

3. Increased Transparency of Costs

The regulation also introduces enhanced transparency requirements related to quotations and pricing structures from Notified Bodies.

Under the new framework, quotations should include:

• Number of sites involved

• Identification of the device(s)

• SME status of the manufacturer (micro, small, or medium-sized enterprise)

• Breakdown of costs associated with:

• QMS assessments

• Technical Documentation reviews

• Surveillance activities

• Unannounced audits

This increased transparency is expected to help manufacturers better understand the financial implications of conformity assessment activities.

Impact on Manufacturers

The publication of Regulation (EU) 2026/977 represents a potentially important improvement for manufacturers navigating the EU MDR and IVDR certification environment.

Greater Planning Certainty

The introduction of defined maximum timelines may significantly improve:

• Product launch planning

• Resource allocation

• Market access forecasting

• Internal project management

• Coordination with distributors and importers

Better Budget Forecasting

The requirement for detailed cost breakdowns should allow manufacturers to:

• Compare quotations more effectively

• Understand cost drivers

• Improve budgeting accuracy

• Reduce unexpected certification expenses

More Consistent Conformity Assessment Experience

Although some operational differences between Notified Bodies will likely remain, the regulation aims to reduce major inconsistencies that have affected manufacturers since MDR and IVDR implementation.

Impact on Notified Bodies

Notified Bodies themselves will also face increased operational expectations.

The regulation may require NBs to:

• Standardize internal procedures

• Improve resource management

• Increase transparency in customer communications

• Monitor and report timelines more systematically

• Optimize audit and review workflows

The regulation could also increase scrutiny regarding NB performance and consistency across the European regulatory system.

Application Dates

The Implementing Regulation will apply from 25 February 2027 onward.

However, one important provision has a later implementation date.

The annual reporting obligations on timelines and costs of conformity assessment activities will apply from 1 January 2028.

Manufacturers and Notified Bodies should therefore begin preparing for implementation well before the regulation becomes fully applicable.

eNEWS Summary Published by the European Commission

The European Commission also summarized the regulation in an eNEWS publication titled:

“Medical Devices: New Implementing Regulation sets out uniform requirements for conformity assessment and notified bodies”

The eNEWS communication emphasized the broader objective of strengthening consistency and predictability within the EU medical device regulatory framework.

Recommended Actions for Manufacturers

Manufacturers should consider taking several proactive steps in response to Regulation (EU) 2026/977:

Review Existing Notified Body Agreements‍

Organizations should assess whether current agreements and quotations from their Notified Bodies align with the new transparency expectations.

Update Regulatory Planning Assumptions‍

Regulatory teams may need to revise project planning assumptions and certification timelines based on the newly defined maximum assessment periods.

Monitor Future Guidance‍

Additional MDCG guidance documents or implementation clarifications may be published before February 2027.

Manufacturers should continue monitoring updates from the European Commission and competent authorities.

Engage Early with Notified Bodies

Manufacturers currently planning MDR or IVDR conformity assessments should discuss with their Notified Bodies how implementation of Regulation (EU) 2026/977 may affect future certification activities.

Conclusion

Regulation (EU) 2026/977 represents a significant step toward greater harmonization, transparency, and predictability within the European medical device conformity assessment system.

By establishing common procedural expectations, defined timelines, and clearer cost structures for Notified Bodies, the European Commission aims to improve consistency across the MDR and IVDR regulatory landscape.

For manufacturers, the regulation may provide better planning certainty and improved transparency during certification activities. At the same time, both manufacturers and Notified Bodies will need to prepare operationally for the new requirements ahead of their application in February 2027.

Further information can be found through the official European Commission and EUR-Lex publications:

• EUR-Lex Regulation (EU) 2026/977  

• European Commission DG SANTE Newsletter Archive

Learn more about

• EU Medical Device Classification & Regulation (MDR/IVDR)

‍