Today, at a conference in Brussels, the European Commission shared important points and dates regarding the MDR implementation and preparedness of the regulatory framework, and…
Combination products: MDCG provides guidance on UDI-related obligations
The MDCG endorsed a new guidance on the UDI-related obligations when it comes to medical devices that administer/incorporate medicinal substances, human tissues and cells as…
MDCG Position on Content of the certificates, voluntary certificate transfers just published!
The MDCG endorsed a Position document – Guidance on content of the certificates, voluntary certificate transfers where it discussed: Content of the certificate under MDR…
NBs on Classification Rule 8 of the MDR
NB-Med and Team-NB issued a Joint Position Paper to ensure more harmonized classification of implantable devices and long-term surgically invasive devices under the new MDR…
MDCG guiding principles for issuing entities: Basic UDI-DI
MDCG (Medical Device Coordination Group) stated in the newly published guiding principles for issuing entities rules that the Basic UDI-DI requirements on format should be…
NEW eBOOKS: How will the new Regulations (MDR/IVDR) impact you?
We are happy to announce the below two new publications that were added to our MDlaw e-shop! MDR eBOOK IVDR eBOOK In approximately 200 pages,…
First NB designated under the MDR !
The European Commission announced the designation of the first Notified Body under the new Regulation on Medical Devices in the NANDO database! The first NB…
IVDR: Team-NB Survey on NB designation process
This time, Team-NB performed a survey on the designation process of Notified Bodies (NBs) under the IVDR and currently: From 20 Team-NB notified bodies…
EC public reply to PIP fraud Petition
The European Commission (EC) published a public letter to the PIP Implants World Victims Association and rejected the petition to claim the financial compensation at…
New UK guidance: ”no deal” scenario
The UK Government issued a new guidance in the beginning of the year on how a ”no deal” Brexit will affect the regulatory framework of…