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…
25 MDR Notified Bodies & EUDAMED Implementing Act
The NANDO database newly lists 25 Notified Bodies under the MDR! SGS Belgium NV has been the latest NB notified under the Regulation (EU) 2017/745 on…
EUDAMED: NB & Certificates – Useful documents
EUDAMED or the European database on medical devices has been designed to support the implementation of the EU Medical Devices Regulations. EUDAMED is composed of…
IVDR Implementation plan: What is the status of the main priorities?
The MDCG has released the updated Joint implementation and preparedness Plan for IVDR noting significant progress has been achieved. For example, The necessary implementing acts…
Timeline for MDCG guidance documents updated
The European Commission has released the updated document on the ongoing work of the MDCG and its subgroups. We present you below some of the…