Recognition of European Standards to support Medical Devices Regulations progresses

European Commission set to add to list of Harmonised Standards in the Official Journal

Harmonized European Standards have an important, specific role in supporting the European Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).  Article 8 of each Regulation indicates, that Harmonized Standards referenced in the Official Journal (OJ) of the European Union, provide a presumption of conformity with relevant requirements of the Regulation covered by those standards or applicable parts of standards. The presumption of conformity also applies to system or process requirements, including those requirements relating to quality management systems and risk management.

European Standards that are harmonized include a European Foreword and Annex Z. These parts of the standard describe the relationship between the requirements of the standard and the regulatory requirements in the European Regulations, taking account of the scope of the standard.  The drafts of the European Foreword and Annex Z are reviewed on behalf of the European Commission by Harmonised Standards (HAS) Consultants. The role of the HAS Consultants is to assess whether the standards drafted by the European Standards Organizations comply with the European Commission requests as outlined in the relevant standardization request. The consultants also consider the extent to which they deal with and support relevant requirements for general safety and performance (GSPR) or other criteria set by the legislation. There has been a hiatus in HAS Consultant assessments of standards as the contract to manage the process had expired. The new contract to manage the system was announced in August 2022. Individual agreements with HAS Consultants are finalised to enable the restarting of their activities. The HAS consultant team for IVDs will consist of up to seven experts. This is intended to provide flexibility with individuals with different expertise being available to support the work.

A Standardization Request from the European Commission to the European Standards Organizations, CEN and CENELEC, provided the legal basis for harmonising standards for the MDR and IVDR. On 12 May 2021, the European standards organizations, CEN and CENELEC, formally accepted the Standardization Request from the European Commission for standards to support the MDR and IVDR. Agreement of this request allowed publication of references to Harmonised Standards that provide a presumption of conformity under the MDR and IVDR to start. The request is not a static document, but it will be the starting point for systematic updates when necessary for lists of standardisation items and deadlines for the adoption. A draft amendment to add and to remove some items was presented to of the Committee on Standards under the Standardisation Regulation (EU) No 1025/2012 for an opinion at their meeting on 22 November 2022.

In addition, a list of further references to Harmonised Standards for the MDR and IVDR for the OJ is currently in preparation and it is hoped to be published shortly.

Manufacturers using standards to support conformity with the MDR and IVDR should be aware of the progress in development of further Harmonised Standards, the additions to the standardization request and watch out for publication of the further lists of Harmonised Standards for the MDR and IVDR in the OJ.