Today the Medical Device Coordination Group (MDCG)* released a new Position Paper:

MDCG 2022-14: Transition to the MDR and IVDR – Notified Body capacity and availability of medical devices and IVDs

Due to concerns about disruption in the supply of devices in Europe, the MDCG was called upon to propose solutions regarding Notified Body capacity and medical device manufacturers’ MDR/IVDR readiness.

Below are some of the solutions proposed by the MDCG.

Increase Notified Body Capacity:

• Use of hybrid audits, where this would contribute to conducting the conformity assessment in a timely and efficient manner
• Where practicable, to avoid duplicating work Notified Bodies are encouraged to leverage evidence from the manufacturer’s previous assessments conducted under the old Directives
• Reminder that while MDCG guidance documents are to assist industry in how to apply legal requirements in a harmonized way, industry should be allowed flexibility as to how to demonstrate compliance to the legal requirements
  • Further, new guidance should not be immediately applied to ongoing processes or applications already launched, unless use of such guidance increases the efficiency
• Reminder to Notified Bodies of their obligation to make their standard fees publicly available, and to take in to account the interest of small-to-medium enterprises (SMEs)
• Request to Notified Bodies to develop schemes to allocate capacity to small-to-medium manufacturers and first-time applicants, and ensure those parties access to the market
• MDCG will review its guidance to find ways to eliminate Notified Body administrative workload
• Prioritize release of EUDAMED modules so that Notified Bodies can automate more, e.g., upload relevant information machine-to-machine
• Defer the Notified Body’s first reassessment audit from three years to five years; under the current schedule, 10 re-assessments are scheduled for 2022, 12 for 2023 and 11 for 2024
  • This is to allow designating bodies to concentrate on assessment of new Notified Bodies and for MDR/IVDR accredited Notified Bodies to concentrate on processing manufacturer applications

Increase Preparedness of Manufacturers:

• Reminder to manufacturers to not postpone their transition to MDR/IVDR CE marking
  • Specifically, a notice for IVD manufacturers, to make use of the current available IVD Notified Body capacity, instead of waiting until the end of the transition period
• Encourages manufacturers and Notified Bodies to organize structured discussions before and during the conformity assessment process, related to regulatory procedures and to enhance the efficiency of the conformity assessment process
• Due to the high-level standards required by the MDR/IVDR, requests for all parties to ‘step up communications with manufacturers by means of webinars, workshops…’
  • For examples, Notified Bodies can present information about common non-conformities, and best practices on preparation and content of technical documentation
  • As reported previously, a high percentage of MDR/IVDR applications have been reported as incomplete
• Reduce complexity of conformity assessments for ‘safe and effective’ ‘legacy’ devices
  • Additional guidance should be provided to assist with the practical application of clinical evaluation (MDR, Article 61) and possibly also performance evaluation and clinical evidence (IVDR, Article 56)
  • Make appropriate use of MDCG guidance on clinical evidence for legacy devices and clinical evaluation-equivalence
• Request that EU medicines authorities efficiently process consultations by Notified Bodies for devices that incorporate an ancillary medicinal substance and for companion diagnostics
  • Further, to expedite reviews for devices previously certified under the MDD/AIMDD

The Position Paper ends with a reminder that derogations are only granted in situations that are in the interest of public health, patient safety or patient health. And that manufacturers must be able to “demonstrate that they have undertaken all reasonable efforts to transition to the Regulations” in order to be eligible. 

*The MDCG is made up of medical and industry experts, and include representatives from all of the EU member states. They aid the EU Commission, and deal with key issues, such as medical device legislation, notified body oversight and market surveillance.