Why this new regulation? 🔍
The European Commission notes that manufacturers are not currently treated uniformly within the European market. Some notified bodies apply very different timeframes for comparable assessments, while quotes and associated costs sometimes lack transparency.
This situation particularly affects:
- SMEs in the medical device sector,
- the predictability of regulatory initiatives,
- time to market,
- and, more broadly, innovation in healthcare.
The new regulation therefore aims to harmonize practices in order to strengthen regulatory safety and ensure the continuity of the supply of medical devices in Europe.
Stricter Requirements for Quotes 💶
The text now establishes a much more specific framework regarding the cost estimates submitted by notified bodies.
Before preparing a quote, the notified body must gather detailed information on:
- the manufacturer and its structure,
- the sites covered by the quality system,
- subcontractors and suppliers,
- the device’s features,
- the risk class,
- as well as the applicable evaluation procedure.
The goal is to avoid situations in which applications are rejected or significantly reassessed after submission because the information provided is deemed incomplete.
Quotes must also include:
- a detailed cost estimate,
- potential additional costs,
- the estimated timeframes for the evaluation,
- as well as the costs associated with surveillance audits, where applicable.
The regulation also stipulates that any cost increase exceeding 10 percent must be explained and justified to the manufacturer.
Harmonized deadlines ⏱️
One of the major changes in the regulation concerns the introduction of harmonized maximum time limits for conformity assessment activities.
Notified bodies must, in particular, comply with the following:
- 30 days to review an application and sign the contract,
- 120 days for the quality management system audit,
- 90 days for product verification,
- 20 days to issue the certificate after the final decision.
The European Commission hopes to reduce the certification delays that are currently affecting the availability of medical devices on the European market.
Guidelines for Suspending Deadlines 📑
The regulation also provides guidelines for suspending deadlines when additional information is requested from the manufacturer.
Until now, these interruptions could significantly prolong the procedures. Going forward, the text sets a maximum number of suspensions for each phase of the conformity assessment process.
This measure aims to:
- improve transparency in trade,
- minimize excessive delays,
- and enhance the predictability of regulatory procedures.
Recertification: Toward a Harmonized Approach 🔄
The regulation also harmonizes the practices for recertifying MDR and IVDR certificates.
As part of a renewal application, manufacturers must provide detailed information regarding:
- the changes made to the system,
- data from postmarketing surveillance,
- updates to the risk analysis,
- developments related to the state of the art,
- as well as the latest clinical or performance evaluations.
Notified bodies will then have a maximum of 90 days to complete the recertification assessment.
The stated goal is to avoid unnecessary comprehensive reassessments while maintaining a high level of security and compliance.
Enhanced Transparency 📊
Finally, the text introduces a new transparency requirement for notified bodies.
Each year, they must publish a report that includes:
- the median certification times,
- compliance with regulatory deadlines,
- as well as the median costs of conformity assessment activities.
This measure will enable manufacturers to better compare the practices of different notified bodies before selecting their certification partner.
Effective Date 📅
The regulation will take effect on February 25, 2027.
👉 This new regulation marks an important step toward the harmonization of MDR and IVDR certification practices across Europe. It is expected to help improve the predictability of procedures, enhance transparency, and further secure market access for medical devices in Europe.
For more information: Implementing Regulation (EU) 2026/977