EU Commission Updates Guidance on SARS-CoV-2 Test Classification
The In Vitro Diagnostic (IVD) expert panel of the European Commission has released new scientific advice regarding SARS-CoV-2. The panel notes that, while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.
This updated assessment may influence the classification of SARS-CoV-2 tests under Regulation (EU) 2017/746. Manufacturers are encouraged to:
- Evaluate how this advice impacts their devices.
- Consult with their notified bodies to determine necessary conformity assessment steps if a change in risk class is warranted.
In the interim, devices can continue to be marketed under their current risk classification, provided they meet all necessary requirements for that class, such as batch testing in accordance with Article 100(2)(b) of Regulation (EU) 2017/746.
The Medical Device Coordination Group (MDCG) is updating its guidance on IVD classification (MDCG 2020-16) to reflect this new advice. It's important to note that both the expert panel's advice and the MDCG classification guidance are not legally binding. Manufacturers should determine each device's risk classification on a case-by-case basis, considering the device’s intended purpose and target population. Additionally, the panel's advice pertains to the current epidemiological context, and manufacturers should consider any changes in this context when evaluating the classification of their tests.
For detailed information, please refer to the official announcement: https://health.ec.europa.eu
MedNet EC-REP GmbH remains committed to keeping our clients informed about regulatory updates that may impact their products. We encourage manufacturers to review this new guidance and assess its implications for their devices.
Latest news
MHRA Introduces New Device Registration Fee: What Manufacturers Need to Know
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its “DORS Fees Guidance 2.1”, introducing a new annual fee model for device registration.
EUDAMED’s first four modules become mandatory on 28 May 2026 - what this means for medical device manufacturers
The European Commission (EC) has formally declared that the first four modules of EUDAMED - the European Database on Medical Devices - will become mandatory as of 28 May 2026.
MedNet EC-REP GmbH to Exhibit at WHX 2026 in Dubai
MedNet EC-REP GmbH is excited to announce its participation in WHX 2026, taking place from February 9–12 in Dubai. As a trusted European Authorized Representative and compliance partner for global medical device manufacturers, we look forward to presenting our comprehensive regulatory services to an international audience.
Implications of the Update to the Borderline & Classification Manual under MDR and IVDR
On 12 September 2025, the European Commission published Version 4 of the Manual on Borderline and Classification under Regulations (EU) 2017/745 and 2017/746, developed by the Borderline and Classification Working Group (BCWG).
Regulatory Affairs Bulletin: Intended Purpose vs Intended Use under MDR & IVDR
European regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) require precise definitions in technical documentation, and the distinction (or overlap) between intended purpose and intended use remains a topic of operational significance.
-250x250.jpg&w=256&q=75)
MedNet EC-REP GmbH at MEDICA 2025 – Visit Us in Hall 3, Booth D43
MedNet EC-REP GmbH is pleased to announce that we will once again be exhibiting at MEDICA 2025 in Düsseldorf, the world’s leading trade fair for the medical technology industry.
EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know
The European Commission has introduced a significant amendment to Implementing Regulation (EU) 2021/2226, impacting how medical device manufacturers provide instructions for use (IFU).
Understanding the Interplay: MDR, IVDR, and the AI Act – Key Insights from MDCG 2025-6
Recently, the MDCG, in conjunction with the Joint Artificial Intelligence Board (AIB), released the MDCG 2025-6 FAQ document, offering essential clarifications on the interplay between the MDR, the IVDR, and the Artificial Intelligence Act (AIA).