MDR/IVDR: Commission invites comments on revisions to standardization request

The European Commission has published a draft amendment to its Implementing Decision C(2021) 2406 to update the list of harmonized standards it will seek to revise or draft in support of the Medical Devices Regulation (MDR). ) and In vitro Medical Diagnostic Devices Regulation (IVDR).

The Commission sent its standardization request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) in 2021, calling on the two standardization bodies to revise or draft more than 200 harmonized standards in three years. (RELATED: MDR/IVDR: the Commission adopts a new standardization request, Regulatory guidance April 16, 2021)

The development of harmonized European standards is a major element of the new regulations for devices and IVDs, as products developed in accordance with the harmonized standards referenced in the Official Journal of the European Union (OJEU) are presumed to comply with the corresponding legal requirements laid down in the MDR and the IVDR.

Several sets of harmonized standards have now been published for device and diagnostic manufacturers to refer to in order to meet compliance requirements under the two regulations, both of which are now in force. (RELATED: The European Commission publishes the second batch of harmonized standards under the MDR, Regulatory guidance January 6, 2022; IVDR: the European Commission publishes a second batch of harmonized standards, Regulatory guidance January 11, 2022; IVDR Implementation Day Overshadowed by Lack of Notified Bodies, Patient Risks, Regulatory guidance May 26, 2022)

In its draft amendment, the Commission states that it may seek “possible future standardization requests from the European standardization organisations”, although it notes that it has not adopted or approved the changes to its standardization request. The Commission invites comments on the proposed amendment until June 30, 2022.

The draft amendment proposed the addition of three new standards to be revised in support of the MDR, including EN ISO 1135-4:2015 Transfusion equipment for medical use – Part 4: Single-use transfusion sets, gravity fed , EN ISO 1135-5: 2015 Transfusion equipment for medical use – Part 5: Disposable transfusion sets with pressure infusion apparatus, EN ISO 10651-4:2009 Lung ventilators – Part 4: Particular requirements for pressure ventilators user supplied.

It also identifies eight new standards to be drafted in support of the MDR, including standards for sterilization of healthcare products, power-assisted chairs used in road ambulances, and requirements for performance classes and methods of testing for respiratory infection prevention devices.

The Commission also proposes to delete six entries currently in the list of new standards to be drafted in support of the MDR concerning radiation protection, active implantable medical devices, surgical implants and electrical medical equipment.

In addition, the Commission proposes to add four standards to the list of new standards to be developed in support of the IVDR, including three relating to sterilization and one on the control of microbial risks during the processing of cell-based products .

If the amendment is adopted, the newly added standards would have an adoption deadline of May 27, 2024.

European Commission