EU moves to align Notified Bodies’ practices under the MDR and IVDR

This Implementing Regulation is a key development for medical device and IVD manufacturers. To date, notified bodies have applied significantly divergent certification practices, leading to uneven treatment of manufacturers across the EU, particularly affecting small and medium-sized enterprises. These inconsistencies had a negative effect on the predictability and timely completion of conformity assessments, contributing to significant delays for manufacturers to achieve certification under the MDR and IVDR. This new Implementing Regulation aims to address these issues by harmonising key aspects of the conformity assessment process.

Standardised quotations

Notified bodies have historically adopted different approaches when issuing quotations for the various certification activities, with the result that manufacturers were not provided with a clear and reliable estimation of the overall requested services and costs.

The new Implementing Regulation aims to harmonise these quotation practices, by requiring notified bodies to have documented procedures in place to ensure that they only issue quotations once they have received specified minimum information from the manufacturer (Article 1). In addition, every quotation must now include at least:

(a) the estimated overall costs, which are detailed for the assessment of the quality management system (QMS) and the technical documentation, as applicable, and include typical costs for surveillance activities and unannounced audits;

(b) an estimation of potential extra costs arising during the assessment activities; and,

(c) the estimated timeline(s).

Furthermore, the notified body must inform the manufacturer in advance about any increase above 10% of the estimated costs, giving reason of such an increase. For manufacturers, this means significantly greater cost predictability and transparency from the outset of the conformity assessment process. These new quotation rules will apply to conformity assessment procedures for which the notified body and the manufacturer signed a written agreement on or after 25 February 2027.

Maximum conformity assessment timelines

Perhaps the most impactful change for manufacturers is the introduction of maximum timelines for each phase of the conformity assessment process. Article 2 sets out the following maximum timelines:

• 30 days for the application review and signature of the contract with the notified body (starting on the day the notified body receives the complete application).
• 120 days for the QMS auditing (starting on the date the notified body initiates the audit programme's first activity).
• 90 days for the product verification (starting on the day the notified body initiates the assessment of the technical documentation).
• 20 days for the decision and certification (starting on the day after the completion of the last QMS or product review and ending on the day the certificates are issued and entered in Eudamed).

Maximum timelines for the assessment of planned substantial changes are also introduced: 30 days for reviewing the proposed change, 90 days for additional conformity assessment activities, and 20 days for issuing the supplement to the concerned certificate(s) (where applicable).

Article 3 of the Implementing Regulation sets out a maximum number of times per each phase that notified bodies may ‘stop’ these timelines for the manufacturer to address non-compliances or duly justified questions and requests from the notified body. In each case, the notified body must agree with the manufacturer on the duration of the interruption and inform the manufacturer in writing.

These new timeline rules will apply to conformity assessment procedures for which the notified body and the manufacturer signed a written agreement on or after 25 February 2027. The Regulation clarifies that expiry of the above maximum timelines or the use of the maximum number of interruptions are not grounds for the notified body’s refusal to issue a certificate or approve a change.

Increased transparency on effective duration and costs

Article 4 of the Implementing Regulation introduces new monitoring and transparency obligations for notified bodies, which will be required to establish a system to monitor the effective duration of their conformity assessment activities and their costs. By 30 April of every year, each notified body must draw up an annual report on its applied timelines and costs and make the report available on its website (as well as inform its supervising authority and the European Commission). For manufacturers, this will allow meaningful comparison of notified body performance and pricing, enhancing competition and informed decision-making. This annual reporting obligation will apply from 1 January 2028.

More harmonised re-certification procedures

The Implementing Regulation brings much-needed clarity to re-certification, an area marked by divergent approaches by notified bodies, ranging from targeted assessment of limited documentation to more comprehensive assessments comparable to those undertaken for initial certification.

For both product and QMS certificates (Articles 5 and 6), manufacturers must lodge an application for re-certification and provide specified documentation, which shall be assessed by the notified body within 90 days of receipt. The final decision on re-certification must be made and certificates re-issued within a maximum period of 20 days following the final review. These new re-certification provisions will not apply to re-certification reviews of certificates expiring before 25 November 2027.

What this means for manufacturers

This Implementing Regulation represents a substantial step towards a more predictable, transparent and harmonised conformity assessment landscape across the EU. Medical device and IVD manufacturers planning to initiate certification under the MDR or IVDR in the near future may wish to consider the timing of their submissions and conclusion of certification agreements in light of the application date of 25 February 2027. Manufacturers approaching re-certification should also plan in advance to ensure that they will be ready to submit the list of information and/documentation required for the re-certification assessment.

Authored by Hélène Boland, Cláudia Mendes Pinto, and Anastasia Vernikou.