MDCG: First Revision on the Guidance on Standardisation for Medical Devices
MDCG: First Revision on the Guidance on Standardisation for Medical Devices
Regulatory Affairs Medical Devices
Tuesday, 09 July 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
On July 2nd, 2024, the Medical Device Coordination Group (MDCG) released a first revision on the guidance on standardization for medical devices (MDCG 2021-05 Revision 1).
Play
MDCG: First Revision on the Guidance on Standardisation for MDs | QbD Group
AI-generated audio
2:13
MDCG 2021-05 Revision 1: Guidance on standardization for medical devices
The scope of this document is to provide guidance on different aspects related to standards in the medical devices sector. This revision includes removal of references to the Directives and integration into those to the Regulations and provides updates on for example state of the art and common specifications.
This updated guidance provides comprehensive insights into the standards in the medical devices sector, aligning with EU legislation requirements such as Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It explains how harmonized European standards, when referenced in the Official Journal of the EU (OJEU), offer a presumption of conformity with legal requirements, and details the development process for these standards, including assessment by Harmonized Standards (HAS) consultants and publication in the Official Journal of the European Union (OJEU).
The document elaborates on the concept of “state of the art” in relation to standards, discusses relevant rulings by the Court of Justice of the EU on standardization issues, and highlights the role of European Pharmacopoeia monographs and common specifications within the regulatory framework. 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, emphasizing that the use of standards is generally voluntary, with some exceptions.
Additionally, it provides numerous references and sources of information on medical device regulations and standardization. Overall, this guidance aims to clarify the intricate relationship between standards, regulations, and conformity assessment in the EU’s medical device sector.
What does it means to you?
MDCG 2021-05 Revision 1 covers comprehensive insights into various standardization aspects within the medical devices sector.
Discover more expert content
Previous
Regulatory Affairs
23 Dec 2024
Revision of MDCG 2019-13 released
MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C...
Regulatory Affairs
5 Mar 2025
Fifth revision to MDCG 2019-6 Guidance document released
MDCG 2019-6 Rev. 5: Questions and Answers on requirements relating to notified bodies.
Regulatory Affairs
10 Jan 2025
New MDCG 2020-16 Revision 3 Guidance Documents Released
MDCG 2020-16 Revision 3: Guidance on classification Rules for in vitro Diagnostic Medical Devices...
Regulatory Affairs
24 Dec 2024
MDCG 2022-3 Rev.1 released
Notified bodies are required to verify product batches of class D IVDs. Therefore, manufacturers...
Regulatory Affairs
27 Jan 2025
Second revision to MDCG 2023-3 Guidance document released
MDCG 2023-3 Rev. 2: Questions and Answers on vigilance terms and concepts as outlined in the...
Regulatory Affairs
23 Dec 2024
Revision of MDCG 2019-13 released
MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C...
Regulatory Affairs
5 Mar 2025
Fifth revision to MDCG 2019-6 Guidance document released
MDCG 2019-6 Rev. 5: Questions and Answers on requirements relating to notified bodies.
Regulatory Affairs
10 Jan 2025
New MDCG 2020-16 Revision 3 Guidance Documents Released
MDCG 2020-16 Revision 3: Guidance on classification Rules for in vitro Diagnostic Medical Devices...
Regulatory Affairs
24 Dec 2024
MDCG 2022-3 Rev.1 released
Notified bodies are required to verify product batches of class D IVDs. Therefore, manufacturers...
Regulatory Affairs
27 Jan 2025
Second revision to MDCG 2023-3 Guidance document released
MDCG 2023-3 Rev. 2: Questions and Answers on vigilance terms and concepts as outlined in the...
Regulatory Affairs
23 Dec 2024
Revision of MDCG 2019-13 released
MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C...
Regulatory Affairs
5 Mar 2025
Fifth revision to MDCG 2019-6 Guidance document released
MDCG 2019-6 Rev. 5: Questions and Answers on requirements relating to notified bodies.
Next
- 1
- 2
- 3
Stay ahead in life sciences
Keeping up with the fast-paced life sciences industry doesn’t have to be overwhelming.
Our newsletter delivers the latest insights, industry updates, and expert content directly to your inbox, helping you stay informed and make smarter decisions.
Twitter Widget Iframe