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.
Background: Why the European Commission Introduced Regulation 2026/977
Under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), notified bodies play a central role in the conformity assessment process for medical devices and IVDs. However, the European Commission observed significant differences in how notified bodies managed quotations, assessment timelines, and re-certification activities in practice.
These inconsistencies contributed to uncertainty, varying market experiences across the EU, and prolonged certification timelines for manufacturers — particularly for small and medium-sized enterprises (SMEs).
Commission Implementing Regulation (EU) 2026/977 was introduced to establish more harmonised and enforceable procedural expectations relating to the operational administration of conformity assessment activities.
While the Regulation does not modify the core conformity assessment requirements under MDR or IVDR, it aims to create greater consistency, transparency, and predictability in how notified body processes are conducted across the European regulatory system.
New Requirements for Quotations (Article 1)
One of the most operationally significant aspects of Regulation 2026/977 relates to the quotation process between manufacturers and notified bodies. Under the new framework, notified bodies may issue quotations only after receiving a defined set of baseline information from the manufacturer.
Information Typically Required Before Quotations Can Be Issued
• Manufacturer identification details, including applicable authorised representative information where relevant
• Information relevant to SME status assessment, such as employee numbers and annual turnover data
• Details of sites covered under the quality management system (QMS), including operational activities and staffing information
• Information relating to relevant suppliers and subcontractors involved in design or manufacturing activities
• Device-related information, including intended purpose, applicable technologies, specific characteristics, and risk classification
• Identification of the applicable conformity assessment procedure(s)
• For change notifications, details relating to the proposed modifications
• For re-certification activities, information relating to the affected certificates and any proposed scope changes
The new requirements are intended to support greater consistency and transparency in quotation preparation and conformity assessment planning across notified bodies operating under MDR and IVDR.
For re-certification activities or change notifications, manufacturers are generally expected to confirm whether previously submitted information remains unchanged, rather than re-submitting the full documentation set each time. This approach is intended to reduce unnecessary administrative burden and streamline ongoing interactions between manufacturers and notified bodies.
What the quotation must contain
Under Regulation 2026/977, quotations issued by notified bodies are expected to provide greater transparency and predictability for manufacturers. Quotations should generally include an estimated overall cost breakdown covering QMS assessment activities, technical documentation review activities, typical surveillance and unannounced audit costs, potential additional costs where applicable, and indicative conformity assessment timelines.
Where additional costs cannot reasonably be predetermined, notified bodies may apply hourly-rate structures for those specific activities. The Regulation also introduces additional transparency obligations where actual costs significantly exceed the original quotation estimate.
Maximum Timelines for Conformity Assessment (Article 2)
The Regulation introduces structured maximum timelines for the various stages of the conformity assessment process under MDR and IVDR. These timelines are linked to defined procedural events and are intended to improve consistency, planning predictability, and operational transparency across notified bodies.
The framework establishes timing expectations for activities including application review, QMS assessment, technical documentation review, product verification, certification decisions, and EUDAMED-related administrative steps.
The Regulation also introduces defined procedural timelines relating to substantial changes, re-certification activities, and associated 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.