The NANDO database newly lists 27 Notified Bodies under the MDR! ITALCERT SRL has been the latest NB notified under the Regulation (EU) 2017/745 on…
IVDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products,…
MDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices,…
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 has been the latest NB notified under the Regulation (EU)…
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 as the implementing law is yet to be introduced. Previously…
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 EU have commonly agreed to delay the date of application…
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 (CID) introducing electronic instructions of use (IFUs) for medical devices.…
Distributors and importers: new MDCG Q&A
The MDCG has published a new Q&A document with the aim to provide more details on the implementation of Articles 13 and 14 and other…
New MDCG guideline & template: Modification to Clinical investigations
The Medical Device Coordination Group (MDCG) has issued a new guidance on clinical investigations under the Medical Devices Regulation 2017/745 (MDR). In this sense, it…
EXPAMED publishes its new Opinion on Performance Evaluation Consultation procedure (PECP)
The expert panel on medical devices and in-vitro diagnostic devices (EXPAMED) has published a new Opinion in the context of the performance evaluation consultation procedure…