---
title: "New Implementing Regulation (EU) 2026/977 on Uniform Requirements for Conformity Assessment and Notified Bodies"
description: "The European Commission's Implementing Regulation (EU) 2026/977 introduces uniform requirements for notified bodies performing conformity assessments under the MDR and IVDR, setting binding timelines, transparent quotations, and streamlined re-certification rules applicable from 25 February 2027."
url: https://qbdgroup.com/en/regulatory-updates/implementing-regulation-eu-2026-977-uniform-requirements-conformity-assessment-notified-bodies
type: "Regulatory update"
language: en
published: 2026-06-11
author: "Kirsten Van Garsse"
category: "Regulatory Update"
publisher: "QbD Group"
citation: "QbD Group, \"New Implementing Regulation (EU) 2026/977 on Uniform Requirements for Conformity Assessment and Notified Bodies\", https://qbdgroup.com/en/regulatory-updates/implementing-regulation-eu-2026-977-uniform-requirements-conformity-assessment-notified-bodies"
---
# New Implementing Regulation (EU) 2026/977 on Uniform Requirements for Conformity Assessment and Notified Bodies
> The European Commission's Implementing Regulation (EU) 2026/977 introduces uniform requirements for notified bodies performing conformity assessments under the MDR and IVDR, setting binding timelines, transparent quotations, and streamlined re-certification rules applicable from 25 February 2027.

On 05 May 2026, the European Commission published a new [Implementing Regulation (EU) 2026/977 introducing uniform requirements for how notified bodies perform conformity assessments under the MDR and IVDR.](https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj)

The Regulation addresses inconsistent practices across notified bodies, particularly regarding timelines, costs, and re-certification, which have created unpredictability and delays for manufacturers.

## Key Points

- **More transparency in quotations:** Notified bodies must provide structured quotes with clear cost breakdowns, timeline estimates, and advance notice of significant cost increases.
- **Binding maximum timelines for conformity assessment:** For the first time, EU-wide timelines are introduced, including:
  - 30 days for application review and contract signature
  - 120 days for QMS audits
  - 90 days for technical documentation assessment
  - 20 days for certification decision and issuance
- **Controlled use of timeline interruptions:** The Regulation limits and structures when timelines can be paused (e.g. for manufacturer responses or external expert input), including maximum numbers of interruptions per phase, improving overall predictability.
- **Greater transparency on notified body performance:** Notified bodies must monitor and publish annual data on timelines and costs, enabling better comparability across the EU.
- **Streamlined and more predictable re-certification:** A more targeted approach is introduced, including:
  - Focus on changes, PMS data, and risk updates
  - Avoidance of repeating full initial assessments
  - Defined timelines (e.g. 90 days for assessment + 20 days for decision)

## Transitional Provisions

**The Regulation will apply from 25 February 2027,** but important transitional provisions apply.

Conformity assessment procedures already covered by a signed agreement before 25 February 2027 are not subject to the new rules on quotations, timelines, and interruptions.

The new requirements on monitoring and reporting timelines and costs apply only to procedures agreed after 25 May 2027, while the updated re-certification rules do not apply to certificates expiring before 25 November 2027.

This phased approach allows manufacturers and notified bodies time to adapt, while ensuring a gradual transition to the new, more harmonised framework.

## Why Is It Relevant

This Regulation is a **major step toward greater predictability, transparency, and consistency** in conformity assessment across the EU. It operationalises and further specifies the requirements set out in Annex VII MDR/IVDR for notified bodies, translating them into clear, enforceable timelines and procedural rules.

By reducing variability in notified body practices, it aims to improve efficiency, reduce delays, and strengthen confidence in the conformity assessment system, ultimately supporting more reliable market access planning.

## What Does This Mean For You

Manufacturers should expect more predictable and structured interactions with notified bodies throughout the conformity assessment process.

You will need to ensure complete and high-quality submissions, as timelines are now fixed and interruptions are limited.

In addition, internal planning should align with the new timelines, while technical documentation and PMS data must be kept continuously up to date, given the more targeted approach to re-certification.

Overall, the Regulation increases expectations for proactive planning and robust documentation, while improving predictability of certification timelines.
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Source: https://qbdgroup.com/en/regulatory-updates/implementing-regulation-eu-2026-977-uniform-requirements-conformity-assessment-notified-bodies — © QbD Group. Quote freely with attribution and a link back.