On 12 December 2025, the European Commission published a draft Implementing Regulation (“the Regulation”) on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies (“NBs”), introducing detailed requirements for NBs operating under the Medical Device Regulations (EU) 2017/745 (“MDR”) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (“IVDR”).

The recitals describe serious systemic challenges that have emerged since the implementation of the MDR/IVDR and the proposals aim to set out a structured resolution to these challenges. An overview of these proposals is set out below. Overall, the Regulation aims to create a harmonised NB landscape that is predictable, transparent, and fair – supporting patient safety while easing unnecessary administrative burdens for manufacturers. Whether this goes far enough to address the challenges identified will have to be seen.

The Regulation is open for public consultation until 23 January 2026. Once feedback has been reviewed by the Commission, it will be published. The Commission  anticipates adoption of the Regulations in the first quarter of 2026, following which it will be sent to the European Parliament and Council for consideration. The timing of the formal adoption of the Regulation is not yet clear.

Key Challenges

  • Divergent and inconsistent interpretations of Annex VII requirements: Notified Bodies have been applying the requirements of Annex VII of the MDR and IVDR, relating to requirements to be met by NBs, differently – in particular regarding quotations, timelines, and re‑certification. This creates fragmentation across Member States.  
  • Major variation in quotation practices: NBs request different levels of information before providing a quotation, resulting in unpredictable cost estimates, rejection of applications because the initial information was incomplete, and unequal treatment across the internal market (which is especially harmful for SMEs).
  • Lack of harmonisation in timelines for conformity assessments: Timelines for technical documentation review, QMS audits, and product verification vary widely. Some manufacturers face long delays, affecting innovation and patient access.
  • Unpredictability in re‑certification practices: NBs differ sharply in what documentation they require during renewal, how deeply they reassess devices, and how long re‑certification cycles take. Some NBs repeat near‑full assessments, others do only minimal checks.
  • Limited transparency on NB performance and costs: There is little visibility on how long assessments actually take, deviations from quoted costs, and NB performance across the EU. Manufacturers cannot therefore compare NB efficiency.
  • Excessive delays caused by back‑and‑forth queries: Unstructured exchanges between NBs and manufacturers slow down conformity assessments, especially when additional expert contributions (EMA, panels, EU labs) are involved.

Proposals on how these challenges should be addressed:

  • Standardised Requirements for Quotations: To address inconsistent quotation practices, unclear cost structures, and unequal treatment of SMEs, Article 1 proposes that NBs may issue a quotation only after receiving a clearly defined set of information. This includes: manufacturer identity and SME status; all manufacturing sites and subcontractors; device description, intended purpose, risk class, and technologies; chosen conformity assessment route; and descriptions of planned changes or scope of re‑certification.  NBs must also provide: detailed cost breakdowns, estimates of extra costs, and travel and accommodation cost estimates. NBs must justify any later cost increases.
  • Uniform Maximum Timelines for Conformity Assessments: Article 2 proposes the introduction of strict, EU‑wide maximum timelines to address slow, unpredictable processes, inconsistent durations, and lack of rationale for NB timelines. Proposal include:
    • 30 days for application review and contract signature,
    • 120 days for QMS audits,
    • 90 days for product verification,
    • 15 days for final decisions and certificate issuance.

It also sets maximum timelines for planned substantial changes to a QMS or a device range covered a MDR/IVDR certificate and permits parallel processes where applicable.

  • Rules on Interrupting Conformity Assessments: To control delays caused by manufacturers needing to address non-compliances, questions and other requests from a NB, which cause unstructured back‑and‑forth, prolonged delays and unclear pauses in the process, Article 3 proposes: capping the number of allowed interruptions per assessment phase, agreeing the duration of the interruption with the manufacturer, requiring these interruptions to be justified,  and separately handling interruptions needed for EMA/expert panel involvement.
  • Mandatory Monitoring & Public Reporting of Timelines and Costs: Under proposed Article 4, to address a lack of transparency and an inability for manufacturers to benchmark NB performance, it is proposed that NBs must implement as part of its QMS a monitoring system to provide details on the duration of conformity assessment activities and associated costs. This will provide information on, amongst other things, the percentage of assessments completed within required timelines, minimum/maximum/median durations for assessment, and total costs and variance from initial quotes.  NBs must publish annual reports on timelines and costs of conformity assessment activities.
  • Launch of Re‑certification: To address unpredictable or late re‑certification, Article 5 proposes that NBs must notify manufacturers one year in advance of certificate expiry.
  • Re‑certification for Product Certificates: To addressoverly divergent document requests and inconsistent depth of review, Article 6 provides a clear list of documentation NBs must require from manufacturers when lodging an application for re-certificate reviews. This includes: changes to the device not yet notified, updated clinical/performance evaluations, PMS and PSUR updates, changes to risk evaluations, and changes due to state‑of‑the‑art developments. NBs must complete this review within 60 days.
  • Re‑certification for QMS Certificates: To address different practices leading to uneven re‑certification workloads, under proposals in Article 7 NBs must require manufacturers to lodge an application for re-certification and the NB will verify that: all required audits occurred during the cycle, all surveillance activities have been completed, non‑compliances have been resolved or are on a CAPA path, sampling plans and audit programmes are up‑to‑date. NB review must be completed within 60 days.
  • Decision on Re‑certification: To address overly burdensome re‑certification assessments, Article 8 proposals limit re‑certification to reviewing the documentation required under Articles 6 and 7, request only limited additional  specific evidence, and issue renewed certificates within 15 days after the positive decision.
  • Transitional & Entry‑into‑Force Provisions: certain Articles will only apply to conformity assessments depending on the timing of when the NB and the manufacturer signed a written agreement. For instance, if this is 3 months after the Regulations coming into force then Article 2 and 3 will not apply, or if this is 12 months after the Regulations coming into force then certain requirements under Article 4 will apply.  Additionally, re‑certification rules do not apply to certificates expiring imminently.

The Regulations will enter into force 20 days after publication in the Official Journal of the EU; however, NB annual reporting obligations under Article 4 will not commence until 2028.