The NANDO database newly lists 27 Notified Bodies under the MDR! ITALCERT SRL has been…
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…
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…
25 MDR Notified Bodies & EUDAMED Implementing Act
The NANDO database newly lists 25 Notified Bodies under the MDR! SGS Belgium NV has been…