One of the main concerns when planning towards compliance with Regulation (EU) 2017/745 on medical devices (MDR) is the clinical evaluation. According to article 61 of the MDR, manufacturers must… Read More
bsi white paper on clinical evaluations
Tag: Notified Body
MDCG 2019-6, rev. 3 lays out provisions for notified body pre-certification services
Back in 2019, the Medical Device Coordination Group (MDCG) published guidance MDCG 2019-6, a Q&A document related to requirements around notified bodies. The Commission has now issued revision 3 of… Read More
bsi article on clinical evaluation requirements under the MDR
Notified body bsi has published an article in February in the Journal of Medical Device Regulation. In this article, bsi is sharing insights on its perspective on how manufacturers should… Read More
EU IVD medical devices sector destined for crisis?
The European Commission has fallen behind when it comes to providing guidance and structures required to support the in vitro medical devices sector in timely compliance with Regulation (EU) 2017/746… Read More
Update on Notified Bodies
Regulation (EU) 2017/745 on medical devices (MDR) is not even three months away and the designation of Notified Bodies is still behind the expectations of the industry and the announcements… Read More
DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR
The European Commission is continuing efforts to designate additional Notified Bodies under the new Regulations. More recently, bsi Netherlands and DARE!! Services have both been designated under Regulation (EU) 2017/745… Read More
New Notified Bodies Designated under the MDR and IVDR
MedTech industry is desperately waiting for more Notified Bodies to be designated under the MDR and IVDR. Two more organizations have now been appointed. You may already have heard the… Read More
News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices
Many important documents and guidance for the implementation of Regulation (EU) 2017/745 on medical devices (MDR) are still missing. In certain aspects, however, things seem to evolve in a direction… Read More
LRQA to Withdraw Notified Body Services
The UK Notified Body Lloyds Register (LRQA) announced that it will not apply for designation under the medical devices and IVD regulations (MDR and IVDR). The announcement comes at a… Read More
Quality Assurance Agreements (QAA)
Only several months before the Regulation (EU) 2017/745 on medical devices (MDR) fully applies it is time for positive aspects: The MDR contains constructive guidance in many crucial aspects, one… Read More
Spain’s Only Notified Body Not Accepting Applications for Certification of New Products
Spain’s only Notified Body, based at the Spanish Agency of Medicines and Medical Products (AEMPS) regulatory agency, which is designated under the EU Medical Devices Directive (MDD) and In Vitro… Read More
EU Authorities Might Review Products in Case of Notified Body (NB) Shortage
It seems that the medtech system is on course for calamity because NB designation under the new EU Regulations 2017/745 and 2017/ 746 on medical devices and in vitro diagnostic… Read More
Notified Body Selection and Change
Notified Bodies have a crucial role in the CE Marking process. Below you will find an overview of the role of Notified Bodies and what is important when selecting and changing… Read More