New EU MDR Notified Body Timelines, Explained

We really have a new acronym now...

This week really feels huge for the medical device industry.

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We’ve already got draft implementing regulation - Ares(2025)11081575 - requirements to be met by ‘notified bodies’ & now MDCG 2025-9 - Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746. All of this before we’ve even seen the targeted evaluation and proposal that will be put forward to negotiations for the EU MDR and IVDR. I’ll link all of the documents at end.

Firstly we’ll go through the draft implementing regulation - Ares(2025)11081575 - requirements to be met by ‘notified bodies’.

This draft implementing regulation essentially looks to lay down more stringent requirements for NBs throughout the conformity process in terms of what they must include in their quotations, timelines they must adhere to, how they should manage interruption or re-certification.

This will certainly be a very welcome things by many manufacturers as this was always a big frustration for lots of people within industry, although I do understand what goes on at NBs sometimes that are totally unique and complex.

The following maximum timelines are established:

• 30 days for the application review and the signature of the contract, starting on the day on which the notified body receives the complete application and ending on the day the contract with the manufacturer is signed

• 120 days for the quality management system auditing in accordance with Section 4.5.2 of Annex VII to Regulation (EU) 2017/745 or with Section 4.5.2 of Annex VII to Regulation (EU) 2017/746, as applicable, starting on the date the notified body initiates the audit programme’s first activity and ending on the day in which the final review referred to in Section 4.7 of Annex VII to Regulation (EU) 2017/745 or in Section 4.7 of Annex VII to Regulation (EU) 2017/746, as applicable, is completed;

• 90 days for the product verification in accordance with Section 4.5.3 of Annex VII to Regulation (EU) 2017/745 and Section 4.5.3 of Annex VII to Regulation (EU) 2017/746, starting on the day the notified body initiates the assessment of the technical documentation of the device or the representative device and ending on the day in which the final review referred to in Section 4.7 of Annex VII to Regulation (EU) 2017/745 or in Section 4.7 of Annex VII to Regulation (EU) 2017/746, as applicable, is completed;

• 15 days for the final decision and certification, starting on the day after the completion of the last relevant final review referred to in point (b) or (c), depending on the conformity assessment procedure requested, and ending on the day the certificates are issued in accordance with Section 4.8 of Annex VII to Regulation (EU) 2017/75 or with Section 4.8 of Annex VII to Regulation (EU) 2017/746, as applicable.

So overall, there is a total maximum timeline of 255 days allocate to NBs to complete the conformity assessment process.

Breakthrough Devices (Btx) MDCG 2025-9

This will be a very welcome document to many manufacturers, and for those that come into existence only after all of these pathways are defined, then they didn’t have to exist without them at least.

Criteria for breakthrough devices:

MD or IVD will be considered a breakthrough device if it meets each of the following criteria:

1. Novelty

The device introduces a high degree of novelty with respect to the device technology, the related clinical procedure, and/or the application of the device in clinical practice,

AND

1. 2. Positive clinical impact o Offering a significant positive clinical impact on patients or public health compared to available alternatives and the state of the art, OR

2. Fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.

The device is expected to provide a significant positive clinical impact on patients or public health, for a life-threatening or irreversibly debilitating disease or condition, by either of the following:

The document is generally very interesting and hits all of the points industry has been calling for. Just because it’s looking like we’ve all got some reading to do over the Christmas break, the main bits that have stood out to me are:

• Section 10.1 - 10.1 Breakthrough status opinion / designation between NBs and expert panels - the document specifies that the manufacturer can file an application with an expert panel at any time in development, however this is likely to be facilitated by the NB. A key point here is that the type and extent of expert panel engagement will depend on the stage of device development, the nature of the evidence available, and the regulatory pathway applicable. For example, early-stage devices may benefit primarily from non-clinical or regulatory scientific advice under the pilot framework (section 10.3), whereas more advanced devices subject to notified body review may later enter a CECP process (section 10.4).

• 11.1 Prioritisation of BtX and access to structured dialogue with NB - NBs are informed to prioritise Btx, coordinate with expert panels, and be proportionate

• 11.4 Certification with Specific Conditions or Provisions - I’m a big fan of certification with conditions, so glad to see this put into writing as it is a very useful and risk based approach to be able to place a device on the market with conditions, monitor it’s safety and effectiveness through PMS, while gathering with PMCF and market data.

I’ll be really interested to see MDCG 2025-9 applied, manufacturers are expected to lead the designation activity through an application to expert panels, this will likely be done through NBs to consult expert panels in line with article 106 of 2017/745 & 2017/746. This may bring its own unique capacity challenges.

The document nicely highlights some benefits of being designation as a Btx:

• Scientific and Regulatory advice:

  • Priority in EMA expert panel early scientific advice

  • Scientific advice to non-Art.61(2) BtMD and BtIVD (pilot)

  • Regulatory advice

  • Early and priority structured dialogue with NBs

• CI/PS supports:

  • Dedicated CI/PS pre-submission meetings

  • Supports/advice for early feasibility studies

  • Priority selection in CI/PS coordinated assessments (MDR A.78 / IVDR A.70)

  • Proportionate fees for CI/PS authorisations

• Conformity assessment:

  • Enhanced predictability for conformity assessment timelines and expectations

  • Priority structured dialogue with NB

  • Proportionate fees for BtX conformity assessment

  • Accelerated conformity assessment timelines

  • Special considerations re pre-clinical evaluation

  • Certification with conditions to facilitate safe, early market access

• Pre-clinical and clinical evaluation

  • Additional considerations re standards, pre-clinical evidence for BtX

  • Guidance re meeting pre-clinical GSPRs in the absence of well-defined standards for BtX,

  • Guidance re clinical development strategies for BtX, including considerations for suitable CI designs in early, pre-market confirmatory, and post-market stages – see Appendix A.2

  • Guidance on sufficient clinical evidence for conformity assessment

  • Increased role of PMCF for post-market confirmation of safety and performance

• Cross-body recognition of BtX designation status for:

  • HTA assessments

  • EU and national grants and financial supports

Oh and we’re also just expecting the targeted evaluation...Thanks again!