The NANDO database has a new Notified Body under the MDR! Scarlet NB B.V. is the 42nd EU Notified Body notified under the Regulation (EU)…
MDR: 41st Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. is the 41st EU…
MDR: 40th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi is the 40th EU Notified Body…
IVDR: 12th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Sertio Oyis the 12th EU Notified Body notified under the Regulation (EU) 2017/746…
EUDAMED delay announced!
The European Commission has officially announced a delay in the full implementation of the EUDAMED database. As mentioned in a previous post, this delay will…
IVDR: 11th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Eurofins Electric & Electronics Finland Oy is the 11th EU Notified Body notified under…
US and EU regulatory systems for medical devices in comparison
Switzerland relies significantly on imported medical devices. With the implementation of the EU Medical Devices Regulation (MDR) and a mutual recognition agreement (MRA) terminated in…
Legacy device manufacturers: Important deadlines & steps
Legacy devices are devices that are typically covered by a valid CE Certificate or are being up-classified by the Regulations and benefit from a special…
Regulatory lookout: Which other new regulations may be applicable to medtech manufacturers?
The EU is preparing and implementing several new legislations that may impact medical device manufacturers in the upcoming years. We will briefly assess some of…
UK: Extension of CE recognition & Registration of extended Certificates
The UK government announced that it intends to prolong the acceptance of CE marked medical devices on the Great Britain market! In Spring 2023, a…