New lists of harmonised European standards under the Medical Devices (MD) and IVD Regulations have been published in the Official Journal of the European Union. There are now 14 standards harmonised under the MD Regulation and 9 standards harmonised under the IVD Regulation. Medical devices biological evaluation, quality management systems, symbols to be used with information to be provided by the manufacturer, … This list includes standards that are central to demonstrating compliance with the general safety and performance requirements of the Regulation.
By their nature, devices that comply with the applicable harmonised standards are presumed to comply with all or part of the regulatory requirements falling within the scope of these standards (see Article 8 of the Regulations). The concept of presumption of conformity has been clarified in the MDCG 2021-5.
Annexes Z of the harmonised standards are very important elements allowing the link between the regulatory requirements and the normative provisions. Three cases exist: the regulatory requirement is covered / partially covered / not covered by the provisions of the standard.
For example, the mention of EN ISO 13485 in the lists of harmonised standards gives the assurance that bringing one’s quality management system (QMS) into conformity with this standard contributes to bringing the QMS into conformity with certain aspects of the regulations related to quality management (cf. article 10 – annexes IX and XI). Nevertheless, attention should be paid to those requirements of the regulations that are not covered or not fully covered by the provisions of the standard, and “direct” means of compliance should be provided.
Further publications of harmonised standards lists are planned until May 2024, when all the standards contained in the European Commission’s request for standardisation should be harmonised. Be careful not to miss any of these publications, as there is no consolidated version to provide a complete list of standards.
nexialist will keep you informed of any future publication of lists, so stay tuned!