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), 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.
The main changes compared to the previous edition are summarised in table form on page 2 of the document.
First of all, there was a significant update of the regulatory reference framework (“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.
Very important for practitioners is the clarification of the concept of state of the art, a crucial element in maintaining high standards of safety and efficacy of Medical Devices.
In addition, here are the main new features introduced by the guidance:
- updates to footnotes and links throughout the document;
- addition of references to new Communications, Guidelines and a ‘Task Force’;
- addition of references to the MDR/IVDR standardisation request and its amendments;
- addition on the role of HAS (Harmonised Standards) consultants;
- information and clarification from CEN and CENELEC: essential aspects for regulatory compliance and meeting health, performance and safety standards in the medical device industry;
- updates on the International Medical Device Regulators Forum (IMDRF);
- addition of a new section (3.6) on European Court of Justice rulings on standardisation;
- A new section was added to European Pharmacopoeia;
- addition of a new section (3.8) on common specifications;
- updates on the CEN-CENELEC Sector Forum on Health Standards (SFHS), formerly known as ABHS.
As specified in the guidance, the contents are not exhaustive and should be read and used in conjunction with the legal framework and guidelines on EU harmonisation legislation for health, safety and performance of products in the internal market, in particular European standardisation. Further information on the legal framework and guidelines can be found in the footnotes of the official document (p. 25 – 27).
The MDCG 2021 – 5 Rev. is a testament to the European Union’s commitment to an ever-increasing rationalisation and harmonisation of the regulatory framework for Medical Devices, keeping pace with technological advances and market needs.
The document proves to be comprehensive and strategic and is likely to become an authoritative reference for all medical device industry and regulatory affairs professionals.
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