New EU Rules for Notified Bodies: How Regulation 2026/977 Brings Predictable Timelines

For several years, medical device manufacturers have faced challenges with timelines in Europe. Two companies with similar devices could approach different Notified Bodies and receive completely different timelines, costs, and procedures. That uncertainty is finally being addressed. 

On 4 May 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/977, published in the Official Journal on 5 May 2026. It lays down uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies designated under the EU MDR (Regulation 2017/745) and IVDR (Regulation 2017/746). The regulation applies from 25 February 2027.

Why Was Regulation (EU) 2026/977 Introduced?

After listening in several forums, requests and analysis activities by the Commission found that Notified Bodies were interpreting Annex VII of the MDR and IVDR inconsistently, especially around quotations, completion timelines, and re-certification. This created wide variation in cost and turnaround for similar work, with a disproportionate impact on small and medium-sized manufacturers. Using its powers under Article 36(3) of the MDR and Article 32(3) of the IVDR, the Commission has now set a single procedural standard for every designated Notified Body in the EU.

Binding Maximum Timelines

The biggest win for manufacturers is predictability. Regulation (EU) 2026/977 sets maximum timelines for the core stages of a conformity assessment:

1. The notified body shall have documented procedures to ensure that the shortest possible timeline is agreed with the manufacturer, taking into consideration the following:

• The range and type(s) of the devices 
• The specific characteristics of the devices and technologies used 
• The devices risk class(es) 
• The conformity assessment activities the notified body is to perform. 

The notified body shall ensure that conformity assessment activities are completed according to the following maximum timelines:

• 30 days for application review and signature of the contract. 
• 120 days for Quality Management System (QMS) audit activities in accordance with MDR and IVDR relevant annex & sections, starting on the date the notified body initiates the audit programme’s first activity and ending on the day in which the final review. 
• 90 days for technical documentation and product verification according to MDR and IVDR relevant sections, starting on the day the notified body initiates the assessment of the technical documentation of each device or each representative device and ending on the day in which the final review. 
• 20 days for the decision and issuing the certificate, starting on the day after the completion of the last relevant final review, depending on the conformity assessment procedure requested, and ending on the day the certificates are issued and entered in the European database on medical devices (‘Eudamed’). 

2. The notified body shall complete the assessment of a planned substantial change to the quality management system or to the device range covered by an EU quality management system certificate or an EU quality assurance certificate, and the assessment of a change to the approved device covered by an EU technical documentation assessment certificate or an EU type-examination certificate, in the following maximum timelines: 

• 30 days for reviewing the proposed planned change. 
• 90 days for the additional conformity assessment activities of the planned change.
• 20 days for issuing the supplement to the concerned certificate(s), where necessary.

The clock can pause only for defined reasons, such as when the Notified Body is waiting for information from the manufacturer or input from expert panels, EU reference laboratories, or the EMA. It resumes as soon as that input arrives. In short, indefinite and unexplained delays are no longer acceptable. 

Entry into force and application

1. Above timelines shall not apply to conformity assessment procedures for which the notified body and the manufacturer signed a written agreement before 25 February 2027.
2. Monitoring of the duration and costs – The notified body shall establish, document and implement, as part of its quality management system some clauses shall apply to conformity assessment procedures for which the notified body and the manufacturer signed a written agreement after 25 May 2027. 
3. Re-certification for product certificates, Re-certification for quality management system certificates & Decision on re-certification shall not apply to re-certification reviews of certificates expiring before 25 November 2027. 

Transparent Quotations and Cost Control 

Generic, lump-sum quotations are out of scope. Importantly, Notified Bodies must follow documented procedures, request standardized information such as SME status and device details, and provide itemized fee breakdowns. If actual costs are expected to exceed the estimate by more than 10 percent, the manufacturer must be informed in advance with justification. 

Structured Dialogue and Public Reporting

Importantly, regulation formalizes structured dialogue between manufacturers and Notified Bodies during the pre-application phase, at no additional fee. This helps align device scope early and reduces surprises later. Notified Bodies must also monitor their performance and publish annual reports comparing quoted versus actual timelines and costs, making it easier to compare Notified Bodies before you commit. 

What Should Manufacturers Do Now?

Predictable timelines only work if your submission is assessment ready. Between now and February 2027, manufacturers should strengthen technical documentation, close QMS gaps under ISO 13485, and prepare complete, consistent application packages. Incomplete submissions will still trigger clock-stops and delays. 

How NexorTest Can Help

At NexorTest, we support manufacturers with EU MDR compliance and CE Marking, EU IVDR compliance, ISO 13485 consulting, technical documentation, and end-to-end testing, regulatory and quality compliance consulting. Getting assessment-ready today means faster, more predictable certification tomorrow. Contact us to plan your 2027 readiness roadmap.