New Revision to MDCG 2020-16 Guidenance Document Released
New Revision to MDCG 2020-16 Guidenance Document Released
Regulatory Affairs In Vitro Diagnostics
Wednesday, 23 April 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
On March 18th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR).
New Revision to MDCG 2020-16 Guidenance Document Released | QbD Group
2:20
This fourth revision of MDCG 2020-16 focuses on devices to detect infectious agents, and in particular SARS-CoV-2.
What is new?
The fourth revision of MDCG 2020-16 is a consequence of the scientific advice on SARS-CoV-2 issued by EMA’s IVD expert panel in late January 2025, and reclassifies devices to detect SARS-CoV-2. Such devices are no longer regarded as Class D under Rule 1, 2nd indent (devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation), but instead are classified as Class B under Rule 6 (devices not covered by Rules 1-5) when not intended for self-testing.
The guidance clarifies that the classification of devices to detect certain moderate-risk infectious agents is not set in stone. In case of changes in the epidemiological context, such as a new strain of an infectious agent, the risk to the individual or public health may change and classification rules 1 or 3 could become applicable and the class of the device revised.
Further, the guidance re-affirms the Class C designation of most devices intended for self-testing by listing self-testing devices intended for the detection of SARS CoV-2 or antibodies against SARS CoV-2 as examples under Rule 4(a).
What does it mean to you?
MDCG 2020-16 Rev.4 is important for manufacturers of devices to detect (solely or amongst others) SARS-CoV-2. Annex XIII of the Common Specifications (Regulation (EU) 2022/1107) no longer applies to such devices as detection of SARS-CoV-2 no longer belongs to risk Class D. Also, detection of SARS-CoV-2 no longer requires devices to undergo performance verification and batch release testing by EU reference laboratories.
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
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
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
27 Jan 2025
New revisions of the Preliminary Assessment Review templates, forms and annexes
The documents are available in the Notified Body section of the MDCG Guidance webpage. The...
Regulatory Affairs
9 Jul 2024
MDCG: First Revision on the Guidance on Standardisation for Medical Devices
MDCG 2021-05 Revision 1: Guidance on standardization for medical devices The scope of this...
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
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
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
27 Jan 2025
New revisions of the Preliminary Assessment Review templates, forms and annexes
The documents are available in the Notified Body section of the MDCG Guidance webpage. The...
Regulatory Affairs
9 Jul 2024
MDCG: First Revision on the Guidance on Standardisation for Medical Devices
MDCG 2021-05 Revision 1: Guidance on standardization for medical devices The scope of this...
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
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...
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