Annex VII Revision: Practical Considerations under Implementing Regulation (EU) 2026/977

Key Changes Introduced by the Revised Annex VII

The adoption of Implementing Regulation (EU) 2026/977 represents an important step in the ongoing implementation of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Through the revision of Annex VII, the regulation introduces additional operational requirements intended to further harmonise conformity assessment practices across the European Union while supporting greater predictability, consistency and transparency in interactions between manufacturers and Notified Bodies. 

Rather than changing the fundamental principles of conformity assessment, the revised Annex VII establishes a more structured operational framework covering some key topics like preparation of quotations, management of assessment timelines, handling of interruptions during conformity assessment activities, monitoring of performance and costs, and re-certification. These provisions will be introduced through phased implementation between February 2027 and January 2028, providing manufacturers and Notified Bodies with time to prepare. 

For manufacturers, the revision of the regulation presents an opportunity to review existing regulatory processes within their organisation and consider implementing provisions like proactive measures to support effective certification planning throughout the product lifecycle. 

What the Revised Annex VII Means for Conformity Assessment

The revised Annex VII introduces several operational measures designed to support a more formal approach to conformity assessment from the earliest stages of the certification process. 

A key change relates to the information that manufacturers are expected to provide before a Notified Body can prepare the quotation. Articles 1 and 2 establish a harmonised set of information requirements intended to enable an accurate estimation of the scope, duration and resources associated with the requested conformity assessment activities. Manufacturers will be expected to provide comprehensive information covering organisational details, quality management system sites, relevant suppliers and subcontractors’ information, device characteristics, intended certification scope and the applicable conformity assessment procedures. Based on this information, Notified Bodies will provide cost estimates together with indicative assessment timelines and justifications where significant fee (i.e., > 10%) increases occur during conformity assessment activities. 

The Regulation also introduces defined maximum timelines for key conformity assessment activities, including application review, quality management system audits, technical documentation assessments, decision and certification, (re)certification and, planned change assessments including certificate supplement issuance. The objective is to support greater consistency and predictability in the planning and execution of conformity assessment activities, while recognising that certain assessment activities may be conducted in parallel where appropriate. 

For manufacturers, these provisions provide greater visibility of the different stages of conformity assessment and reinforce the importance of effective planning. As with the existing regulatory framework, successful assessments continue to rely on complete submissions, high-quality technical documentation and timely engagement of all relevant stakeholders throughout the review process. 

How to Prepare for New Submission Requirements

Article 3 complements the new timeline requirements by defining the circumstances under which conformity assessment timelines may be interrupted, commonly referred to as “clock-stops”. 

Interruptions may occur where manufacturers are requested to address non-compliances or provide clarifications or additional information during conformity assessment activities. The regulation also establishes limits on the number of interruptions while recognising that certain external consultation procedures remain outside these limits. 

These provisions reinforce the importance of submission readiness. The new requirements may encourage manufacturers to review their internal processes to assess readiness for implementation. This would be  to ensure that the quality management system is compliant and the device’s technical documentation is complete, consistent and supported by appropriate evidence before the formal assessment begins. Effective coordination between regulatory, quality, clinical and technical functions may also help facilitate timely responses to assessor’s questions during assessment activities and for the effective resolutions of any non-conformities raised. 

The revised Annex VII also introduces the concept of a rolling review approach for technical documentation, where agreed between the manufacturer and the Notified Body. While rolling review is well established in other regulatory settings, its explicit inclusion within the MDR and IVDR framework is new. As highlighted in the white paper, implementation approaches are expected to evolve over time, and practical experience will help clarify its suitability across different device types and levels of complexity. 

New Notified Body Performance Monitoring and Reporting Requirements

The revised Annex VII Article 4 introduces new requirements relating to the monitoring of conformity assessment performance. 

Notified Bodies will be required to establish systems for monitoring key performance indicators relating to conformity assessment activities, including timelines and associated costs. From 2028 onwards, annual reports containing defined performance metrics will also be published on Notified Bodies’ websites and submitted to the European Commission. 

These provisions support broader regulatory objectives of further improving the transparency and enabling comparative evaluation of conformity assessment activities across the system. At the same time, it is also recognised that these measures relating to monitoring and reporting may also increase administrative activities for Notified Bodies. From a manufacturer perspective, greater visibility of performance metrics may contribute to improved certification planning and a better understanding of expected timelines and associated costs. Overall, the practical impact of these measures on stakeholders will become clearer as implementation progresses. 

Re-Certification: What Manufacturers Need to Know

Articles 5, 6 and 7 establish a more focused framework for the re-certification of both product certificates and quality management system certificates. 

Manufacturers will be expected to provide specific information supporting re-certification, including summaries of changes introduced since the previous certification cycle, post-market surveillance outputs, updated risk evaluations and evidence demonstrating continued alignment with the current state of the art. Notified Bodies will assess this information alongside the resolution of previous non-conformities, the implementation of corrective actions and the continued validity of the certification scope. 

The revised framework also reinforces the importance of forward planning. Manufacturers remain responsible for submitting re-certification applications sufficiently in advance to allow assessment and decision-making to be completed before certificate expiry. The Regulation does not require Notified Bodies to provide reminders of approaching expiry dates, making proactive certification planning an important consideration for manufacturers. 

How Manufacturers Can Prepare for Annex VII Implementation

The phased implementation of Implementing Regulation (EU) 2026/977 provides all stakeholders with time to review existing processes and prepare for the revised operational framework. 

The new provisions do not apply retrospectively. Instead, implementation follows clearly defined applicability dates for quotations and timelines, monitoring requirements and re-certification activities. Understanding these transitional provisions will be important when planning certification projects and contractual agreements over the coming years. 

Manufacturers may wish to evaluate how current processes align with the revised framework and identify areas that may require adaptation before implementation. This would compromise of a  detailed analysis  of their documentation management practices, post-market surveillance systems, management of changes etc.  amongst other processes and should consider planning certification activities well in advance to support a smooth transition as the new requirements are progressively introduced. 

What the Annex VII Revision Means for Medical Device Manufacturers

Implementing Regulation (EU) 2026/977 introduces a more structured operational framework for conformity assessment under the MDR and IVDR. Through harmonised information requirements, defined timelines, monitoring obligations and a standardised approach to re-certification, the revised Annex VII seeks to support greater consistency, predictability and increased transparency across the conformity assessment systems. At the same time, its effectiveness will ultimately depend on practical implementation and on maintaining an appropriate balance between predictability and the flexibility required for robust, risk-based conformity assessment activities. 

For manufacturers, early preparation provides an opportunity to review internal processes, strengthen submission readiness and plan certification activities in line with the phased implementation timeline. As the experience with the revised framework develops over time, continued collaboration between manufacturers and Notified Bodies is likely to support effective conformity assessment activities and facilitate timely access to safe and effective medical devices.

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.