How can the capacity and availability of notified bodies be increased?


The Medical Device Coordination Group (MDCG) has issued a position paper to address the issues related to the MDR/IVDR transition, in particular to increase the capacity and availability of notified bodies.

The MDCG states in the introduction to the resolution:

The MDCG recognizes that significant and urgent challenges remain to ensure adequate capacity of notified bodies and readiness of manufacturers to certify medical devices under the MDR/IVDR by the end of the transition period set out in the Regulations.

At the EPSCO Council meeting on 14 June 2022, health ministers expressed their concern that these challenges, if not addressed, could lead to disruption of health systems and the supply of essential supplies for patients. Health Ministers called on the MDCG to urgently propose solutions to address the immediate challenges.

The measures outlined in the document are designed to facilitate more effective application of regulatory requirements, not to reduce, avoid or eliminate them!

In the attached document, the MDCG made 19 proposals in the areas of increasing the capacity of notified bodies, access to notified bodies, increasing the preparedness of manufacturers and other measures to facilitate the transition to MDR/IVDR.

Perhaps the most important proposals for manufacturers are:

  • In order to avoid unnecessary duplication of work, the MDCG encourages notified bodies to develop methods to use evidence from previous assessments under the Directives (MDD/IVDD) and their components in conformity assessment procedures under the Regulations (MDR/IVDR).
  • The MDCG calls on notified bodies to make full use of the flexibility already described in MDCG 2022-4 with regard to the supervision of legacy assets. This includes a combination of Directive surveillance and MDR/IVDR certification audits of legacy devices. It would be advisable to focus on assessing notified bodies' compliance with MDR/IVDR requirements instead of monitoring compliance with the requirements of the Directives (MDD/IVDD)!
  • Reasonable time should be given for the application of new MDCG guidelines, they should not be used in ongoing conformity assessment procedures unless the application of such guidelines would increase the efficiency of the process.
  • The MDCG encourages notified bodies and manufacturers to organise structured dialogues on regulatory procedures before and during the conformity assessment process, where this is useful to increase the efficiency and predictability of the conformity assessment process, while respecting the independence and impartiality of the notified body. Such dialogues shall not be considered as advisory services.
  • The MDCG provides additional guidance to notified bodies and manufacturers to facilitate the practical application of the requirements for clinical evaluation and performance evaluation of IVD devices.
  • The MDCG draws the attention of Notified Bodies to the fact that the MDR/IVDR provides for the possibility to issue certificates subject to conditions, combined where appropriate with the requirement to carry out PMCF/PMPF tests. This option increases flexibility in obtaining clinical evidence for devices with a demonstrable safe track record.

The resolution has assigned responsibilities to each proposal, so we hope that they will be implemented as soon as possible.