MDR/IVDR: Commission seeks comment on revisions to standardization request

Regulatory NewsRegulatory News | 02 June 2022 |  By 

The European Commission has released a draft amendment to its Commission Implementing Decision C(2021) 2406 to update the list of harmonized standards it will seek to have revised or drafted in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
 
The Commission made its standardization request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) in 2021, calling on the two standards bodies to revise or draft more than 200 harmonized standards over the course of three years. (RELATED: MDR/IVDR: Commission adopts new standardization request, Regulatory Focus 16 April 2021)
 
The development of harmonized European standards is a major component of the new device and IVD regulations, as products developed in conformity with harmonized standards referenced in the Official Journal of the European Union (OJEU) are presumed to be in conformity with the corresponding legal requirements laid out in the MDR and IVDR.
 
Multiple batches of harmonized standards have now been published for device and diagnostic makers to reference in order to satisfy conformity requirements under the two regulations, both of which are now in effect. (RELATED: European Commission publishes second batch of harmonized standards under MDR, Regulatory Focus 6 January 2022; IVDR: European Commission publishes second batch of harmonized standards, Regulatory Focus 11 January 2022; IVDR implementation day overshadowed by lack of notified bodies, risks to patients, Regulatory Focus 26 May 2022)
 
In its draft amendment, the Commission states that it may seek “possible future standardisation requests to the European standardisation organisations,” though it notes that it has not adopted or endorsed the any changes to its standardization request. The Commission is seeking comments on the proposed amendment through 30 June 2022.
 
The draft amendment proposed the addition of three new standards to be revised in support of MDR, including EN ISO 1135-4:2015 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed, EN ISO 1135-5:2015 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus, EN ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for user-powered resuscitators.
 
It also identifies eight new standards to be drafted in support of MDR, including standards related to sterilization of healthcare products, power assisted chairs used in road ambulances, and requirements for performance classes and test methods for respiratory infection prevention devices.
 
The Commission also proposes removing six entries currently in the list of new standards to be drafted in support of MDR related to radiation protection, active implantable medical devices, implants for surgery, and medical electrical equipment.
 
Additionally, the Commission proposes adding four standards to the list of new standards to be drafted in support of IVDR, including three related to sterilization and one on the control of microbial risks during processing of cell-based products.
 
If the amendment is adopted, the newly added standards would have a deadline of adoption of 27 May 2024.
 
European Commission

 

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