Notice to third country manufacturers of SARS-CoV-2 IVDs
The competent national authorities have identified several common issues while implementing market surveillance activities (presented…
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MDR: 27 Notified Bodies on NANDO
The NANDO database newly lists 27 Notified Bodies under the MDR! ITALCERT SRL has been…
IVDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195…
MDR Implementation in Estonia
The national law for medical devices in Estonia is the Medical Devices Act RT I…
MDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182…
MDR: 26 Notified Bodies on NANDO & Swiss economic operator’s requirements updated!
The NANDO database newly lists 26 Notified Bodies under the MDR! TÜV NORD CERT GmbH…
Poland: works on the MDR implementation at the national level
Since 26 May 2021, the Regulation (EU) 2017/745 on medical devices directly applies in Poland…
The European Parliament and the Council of the EU adopt IVDR progressive roll-out!
The two co-legislators of the European Union: the European Parliament and the Council of the…
New Regulation on electronic instructions for use of medical devices!
From the next 4th of January 2022 enters into force a new Commission Implementing Regulation…
MDR: How are medical devices regulated in Denmark?
The Danish Ordinance on medical devices and products without medical purpose (BEK nr 957 af…
Distributors and importers: new MDCG Q&A
The MDCG has published a new Q&A document with the aim to provide more details…
New MDCG guideline & template: Modification to Clinical investigations
The Medical Device Coordination Group (MDCG) has issued a new guidance on clinical investigations under…
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