{"id":32875,"date":"2024-07-22T14:47:45","date_gmt":"2024-07-22T12:47:45","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/07\/22\/mdcg-2021-5-rev-1-aggiornata-guidance-on-standardisation-for-medical-devices\/"},"modified":"2024-07-22T15:08:29","modified_gmt":"2024-07-22T13:08:29","slug":"mdcg-2021-5-rev-1-aggiornata-guidance-on-standardisation-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/07\/22\/mdcg-2021-5-rev-1-aggiornata-guidance-on-standardisation-for-medical-devices\/","title":{"rendered":"MDCG 2021-5 Rev. 1: Updated ‘Guidance on Standardisation for Medical Devices’"},"content":{"rendered":"

On July 2, 2024, the Medical Device Coordination Group (MDCG) published the updated version of the ‘Guidance on standardisation for medical devices’ (MDCG 2021-5 Rev.1)<\/strong>, which aims to provide guidance and clarification on various aspects of standards in the medical device sector, in support of the requirements set out in the applicable EU regulations.<\/h2>\n

The main changes compared to the previous edition are summarised in table <\/strong>form on page 2 <\/strong>of the document.<\/p>\n

First of all, there was a significant update of the regulatory reference framework <\/strong>(“New Legislative Framework”) and, in particular, references to the old Directives were removed, and links to the MDR (EU) Regulations 2017\/745, IVDR (EU) 2017\/746 and their amendments were integrated, and EN ISO 15189 and ISO 14155:2011 were added. The update reflects the European Union’s broader strategy to rationalise and modernise regulatory references under the new legislative framework.<\/p>\n

Very important for practitioners is the clarification of the concept of state of the art<\/strong>, a crucial element in maintaining high standards of safety and efficacy of medical devices.<\/p>\n

In addition, here are the main new features <\/strong>introduced by the guidance:<\/p>\n