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
All posts by Michael Sander
Performance Evaluation for IVD Medical Devices
Performance evaluations will take an integral part in the CE Marking process of in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR). This article outlines,… 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
BfArM Informs about Insufficient Labeling of Speaking Valves
BfArM, the German Federal Institute for Drugs and Medical Devices, was informed that accessories for patients treated in tracheostomy procedures are currently insufficiently described in normative terms. The German Standardization… Read More
Recommendation of BfArM regarding Breathing Hoses in Anesthesia
BfArM, the German Federal Institute for Drugs and Medical Devices, has become aware of risk reports in which patients have been harmed as part of anesthesia induction. Risk of Possible… Read More
Most Important Changes – Regulation (EU) 2017/745 on Medical Devices (MDR)
You are a medical device manufacturer and have CE marked your products under the Medical Devices Directive 93/42/EEC (MDD) or the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)? Then you must transition… Read More
Most Important Changes – Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
You are a medical device manufacturer and have CE marked your products under the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD)? Then you must transition to the IVDR in the… Read More
BfArM Recommendation on Paclitaxel-coated Stents and Balloons
BfArM, the German Federal Institute for Drugs and Medical Devices, recently published a warning notice for patients, users and manufacturers of stents and balloons that are coated with Paclitaxel. A… 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
European Commission Confident that the MDR and the IVDR are on Track
Despite warnings about hold-ups at Notified Bodies and products failing to be certified under the new Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU)… 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
Technical Documentation Requirements under the MDR – a Case Study
You may already have asked yourself how Regulation (EU) 2017/745 on medical devices (MDR) affects the Technical Documentation requirements for your products. This is a very complex question and cannot be… 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
Why is a Clinical Evaluation so Important?
Both, the Medical Devices Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 on Medical Devices (MDR) require manufacturers of medical devices to draw up a clinical evaluation for their devices. The overall aim… Read More
Labeling Changes under the Regulation (EU) 2017/745 on medical devices (MDR)
The MDR brings many challenges for medical device manufacturers. Certainly, an area that requires increased attention and careful planning is labeling. Section 23 of annex I of the MDR defines… Read More
How to change your EU Authorized Representative
Don’t worry about changing your EU Authorized Representative! The process became much more formal, but not complicated. We guide you through. Change process under the MDR / IVDR Under the… Read More
OEM – Private Labeling
OEM/Private Labeling was a common concept under the AIMDD, MDD and IVDD. Under the MDR and IVDR requirements are much stricter. Get a quick overview, why your products are affected… Read More