EU Regulation 2026/977: Updates on Notified Body Rules
The European Commission has adopted Commission Implementing Regulation (EU) 2026/977, establishing harmonised rules governing how notified bodies manage quotations, conformity assessment timelines, and re-certification processes. For manufacturers of medical devices and in vitro diagnostic (IVD) medical devices, the regulation introduces greater regulatory predictability while also creating new compliance expectations.
REGULATORYCE
Under the Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), notified bodies are essential in the conformity assessment process for medical devices and IVDs. Nevertheless, the European Commission noted considerable discrepancies in the management of quotations, assessment timelines, and re-certification activities by notified bodies in practice.
These inconsistencies led to uncertainty, diverse market experiences across the EU, and extended certification timelines for manufacturers — particularly affecting small and medium-sized enterprises (SMEs).
The Commission Implementing Regulation (EU) 2026/977 was put in place to create more harmonised and enforceable procedural expectations regarding the operational administration of conformity assessment activities.
Although the Regulation does not alter the fundamental conformity assessment requirements under MDR or IVDR, it seeks to enhance consistency, transparency, and predictability in the procedures conducted by notified bodies across the European regulatory framework.
New Requirements for Quotations (Article 1)
One of the most significant operational aspects of Regulation 2026/977 pertains to the quotation process between manufacturers and notified bodies. Under the new framework, notified bodies may provide quotations only after acquiring a defined set of baseline information from the manufacturer.
Information Typically Required Before Quotations Can Be Issued
• Manufacturer identification details, including any relevant authorised representative information
• Information pertinent to SME status assessment, such as employee counts and annual revenue data
• Details regarding sites included under the quality management system (QMS), encompassing operational activities and staffing information
• Information concerning relevant suppliers and subcontractors involved in design or manufacturing processes
• Device-related information, including intended use, applicable technologies, key characteristics, and risk classification
• Identification of the relevant conformity assessment procedure(s)
• For change notifications, information about the proposed modifications
• For re-certification activities, details about the affected certificates and any suggested changes in scope
The new requirements aim to enhance consistency and transparency in the preparation of quotations and planning of conformity assessments across notified bodies operating under MDR and IVDR.
For re-certification activities or change notifications, manufacturers are typically expected to verify whether previously submitted information is still accurate, instead of resubmitting the complete set of documentation each time. This approach is designed to alleviate unnecessary administrative burden and simplify ongoing interactions between manufacturers and notified bodies.
What the Quotation Must Contain
Under Regulation 2026/977, quotations issued by notified bodies should ensure greater transparency and predictability for manufacturers. Quotations are generally expected to include a detailed overall cost breakdown encompassing QMS assessment activities, technical documentation review activities, typical surveillance and unannounced audit expenses, any potential additional costs where applicable, and indicative timelines for conformity assessment.
If additional costs cannot be reasonably predicted, notified bodies may implement hourly-rate structures for those specific services. The Regulation also establishes further transparency obligations when actual costs significantly surpass the initial quotation estimate.
Maximum Timelines for Conformity Assessment (Article 2)
The Regulation establishes structured maximum timelines for the various phases of the conformity assessment process under both MDR and IVDR. These timelines are associated with specific procedural events and are designed to enhance consistency, planning predictability, and operational transparency among notified bodies.
The framework sets timing expectations for activities including application review, QMS assessment, technical documentation review, product verification, certification decisions, and administrative steps related to EUDAMED.
The Regulation also introduces defined procedural timelines for substantial changes, re-certification activities, and related conformity assessment processes.
The full text of Commission Implementing Regulation (EU) 2026/977 is available in the Official Journal of the European Union (L Series), published on 5 May 2026.