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…
Norwegian legislation on medical devices: MDR implementation
The Regulation (EU) 2017/745 on medical devices (MDR) was implemented into national law of Norway…