On 5 May 2026, the European Commission published an implementing regulation setting new procedural requirements for Notified Body assessments in medical device and IVD conformity assessment procedures (the “Implementing Regulation”). The Implementing Regulation aims to give manufacturers greater certainty in their interactions with Notified Bodies during the initial conformity assessment process and in post-market modifications and re-certifications, as well as aiming to avoid inconsistent practices between Notified Bodies.
To achieve these objectives, the Implementing Regulation sets maximum timelines for Notified Body assessments, provides for standardised rules around quotes by Notified Bodies for carrying out assessments and standardises certain information and verification requirements. The Implementing Regulation also requires each Notified Body to monitor and report on the duration and costs of its assessment activities. Manufacturers will, therefore, have better oversight of the performance of each Notified Body when selecting one to carry out an assessment.
The Implementing Regulation has been developed in response to the inconsistent and divergent interpretation of the procedures for Notified Body assessments under the EU Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), which makes the processes unpredictable for manufacturers.
What are the standardised rules for Notified Body quotations?
Manufacturer must submit a standardised set of information to a Notified Body before it will issue a quotation for carrying out an assessment, thus allowing the Notified Body to provide a more accurate estimate. When providing the quote, Notified Bodies will be required to set out more clearly what the estimate covers.
Notified Bodies must also pre-notify the manufacturer when there is any increase of above 10% of the estimated costs.
Manufacturers should therefore have greater certainty over the costs of the fees payable to their Notified Body.
What are the new timelines for Notified Body pre-market conformity assessment activities?
The Implementing Regulation requires that Notified Bodies must have procedures to ensure the shortest possible timeline is agreed with the manufacturer for carrying out the conformity assessment activities taking account of, amongst other things, the relevant device and its risk classification.
In addition, the Implementing Regulation sets out the following maximum timelines for carrying out the following activities in the initial certification process:
| Activity | Maximum timeline |
| Application review and signing of the contract | 30 days (starting from receipt of the manufacturer’s completed application) |
| Audit of the manufacturer’s quality management system (QMS) | 120 days (starting from the date the Notified Body initiates the audit programme) |
| Product verification | 90 days (starting from the date the Notified Body initiates the assessment of the technical documentation) |
| Decision outcome and issuing certification | 20 days (from the last relevant final review) |
The Implementing Regulation permits “clock-stops” in these timelines to allow the manufacturer to respond to requests for further information or to address non-compliances. Clock-stops are also permitted where an opinion is required from other bodies such as the European Medicines Agency, regulatory authorities and reference laboratories.
What maximum timelines apply for assessment of post-market changes?
The Implementing Regulations also sets the following maximum timelines for Notified Body assessment of a planned substantial change to the manufacturer’s QMS or to the device range covered by a certificate, and for assessment of a change to the approved device covered by an EU technical documentation certificate or an EU type-examination certificate:
| Activity | Maximum timeline |
| Review of planned change | 30 days (starting on the date the Notified Body receives the information on the planned change from the manufacturer) |
| Any additional conformity assessment activities required (where necessary) | 90 days (starting on the date the Notified Body initiates any audit programme) |
| Issuing supplement to relevant certificate | 20 days (starting on the date the Notified Body notifies the manufacturer of approval of the change) |
“Clock-stops” can also apply for post-market changes.
If a new full conformity assessment is required, the timelines for the initial assessment will apply instead.
What effect will the Implementing Regulation have on re-certification procedures?
Manufacturers will also benefit from more standardised approaches to, and timelines for, re-certifications.
For re-certifications for product certificates, manufacturers will be required to provide a standardised set of minimum information, including regarding any changes since the initial certification, as well as certain post-market surveillance information.
The Notified Body must assess this documentation within a maximum of 90 days from receipt.
For re-certifications for QMS certificates, the scope of the Notified Body assessment will be limited to verifying a standardised set of information and indicators as set out in the Implementing Regulation. The Notified Body must complete the assessment within 90 days.
For each of product and QMS re-certifications, the Notified Body must issue the certificate within 20 days of the final review carried out as part of the assessment.
When will the new rules apply?
The Implementing Regulation will apply from 25 February 2027. However, the transitional provisions provide that:
- the rules on quotations and timelines for the initial conformity assessment processes for a device will not apply to any conformity assessment where the Notified Body and manufacturer signed the relevant contract before 25 February 2027;
- the rules on re-certifications will not apply to re-certification reviews for certificates expiring before 25 November 2027; and
- requirements for Notified Bodies to monitor their own performance in relation to timelines and costs shall apply to conformity assessments for which the agreement was entered into after 25 May 2027 (and the obligation to annually report the performance metrics will apply from 1 January 2028).
Please contact us if you have any questions in relation to this important development or if you need any legal or regulatory support.