New guide MDCG 2021-5 rev1 - Guidance on standardisation for medical devices

The Medical Device Coordination Group (MDCG) has released this morning an updated guidance document (MDCG 2021-5 Rev. 1) on standardisation for medical devices. From the previous version, references to the old Directives have been removed, references to the new Regulations (MDR and IVDR) have been integrated, references to EN ISO 15189 and ISO 14155:2011 (but not the 2020 version?) have been added, etc.

𝐊𝐞𝐲 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬:

1. It provides guidance on aspects related to standards in the medical devices sector, supporting requirements in EU legislation.

2. It covers the EU legislative framework for medical devices, including Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

3. The document explains the role of harmonized European standards in providing presumption of conformity with legal requirements when referenced in the Official Journal of the EU (OJEU).

4. It discusses the development process for harmonized standards, including assessment by HAS consultants and publication in the OJEU.

5. The concept of "state of the art" in relation to standards is explained.

6. It covers relevant rulings by the Court of Justice of the EU on standardization issues.

7. The document mentions the role of European Pharmacopoeia monographs and common specifications in the medical device regulatory framework.

8. It describes the governance structure for standards in the medical devices sector, including the MDCG Subgroup on Standards and the CEN-CENELEC Sector Forum on Healthcare Standards.

9. The document emphasizes that the use of standards is generally voluntary, with some exceptions.

10. It provides numerous references and sources of information on medical device regulations and standardization.

This updated guidance aims to clarify the complex relationship between standards, regulations, and conformity assessment in the medical device sector within the EU.

Key changes:

The document outlines several main changes from the previous version. These changes include:

1. Removal of references to the old Directives and integration of references to the new Regulations (MDR and IVDR).

2. Updates to footnotes and links throughout the document.

3. Addition of references to new Communications, Guidelines, and a "Task Force".

4. New considerations on references to EN ISO 15189 and ISO 14155:2011.

5. Addition of references to the MDR/IVDR standardisation request and its amendments.

6. Updates on the role of HAS (Harmonised Standards) consultants.

7. Addition of considerations on information and clarification by CEN and CENELEC and their Technical Committees.

8. Updates on the International Medical Device Regulators Forum (IMDRF).

9. Updates on the concept of "state of the art".

10. Addition of a new section (3.6) on rulings of the European Court of Justice related to standardization.

11. Addition of a new section (3.7) on European Pharmacopoeia.

12. Addition of a new section (3.8) on common specifications.

13. Updates on the CEN-CENELEC Sector Forum on Healthcare Standards (SFHS), formerly known as ABHS.

14. Additions and updates to references and links at the end of the document.

These changes reflect updates in regulations, court decisions, and standardization processes in the medical device sector since the previous version of the guidance.

Who Can Use This Document:

This document could be used by various stakeholders involved in the medical device industry in the EU, including:

1. Medical device manufacturers - To understand how standards relate to regulatory compliance under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

2. Notified Bodies - To guide their assessment of medical devices against regulatory requirements and harmonized standards.

3. National Competent Authorities - To inform their oversight and enforcement activities related to medical device standards and regulations.

4. Standards Development Organizations - To understand the process for developing harmonized standards for medical devices in the EU.

5. Healthcare providers and institutions - To be aware of the standards and regulatory framework applicable to medical devices they use.

6. Regulatory affairs professionals - As a reference on the EU standardization process for medical devices.

7. Policy makers - To understand the framework for medical device standards in the EU.

8. Researchers and academics - As a resource on medical device regulation and standardization in the EU.

9. Any stakeholders involved in the development, assessment, or use of medical devices in the European market. The document provides detailed guidance on the role of standards, the standardization process, and how standards relate to regulatory compliance for medical devices in the EU. It's likely intended as an authoritative reference for anyone needing to understand this topic in depth.

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European Regulation for Medical Devices MDR 2017/745 have added new requested requirements and these requirements form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.). CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR dossiers in their entirety

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