The MDCG published a guidance document, specifically targeted at manufacturers and Notified Bodies, on the summary of safety and clinical performance (SSCP). The MDR requires…
5th Notified Body under the MDR!
The European Commission announced another designation of a Notified Body under the Regulation (EU) 2017/745 on medical devices. This is the 5th Notified Body accredited…
Commission Implementing Decision under MDR: Expert panels
On 11 September 2019, the Official Journal of the European Union was updated with a new Implementing Decision adopted by the European Commission. The Decision…
Guidelines on phthalates in medical devices finalised
In 2019, the independent scientific committee SCHEER published the Guidelines on the benefit-risk assessment of the presence in certain medical devices of phthalates. The guidance…
First MDR Conformity Certificate issued
We are happy to inform you that the Notified Body BSI UK certified the first device – classified as a IIa device – under Rule…
Another Notified Body designated under the MDR!
The European Commission published another designation of a NB under the Regulation (EU) 2017/745 on medical devices. This is the 4th Notified Body designated under…
3rd Notified Body under the MDR!
We are happy to announce that the European Commission updated the NANDO website with a new name: DEKRA Certification GmbH. DEKRA, the German Notified Body,…
Recent updates to MDR e-book & MDR Deadlines
Following the clarifications from the MDCG, our MDR dedicated e-books were updated to reflect the recent updates and prepare you adequately for the requirements of…
First Guideline on cybersecurity of medical devices incorporating software (MDIS)
Becoming increasingly important also for the med tech sector in view of the technical advancement, cybersecurity aims at incorporating measures, both technical and organisational, that…
Public consultations: reprocessing of single-use MD and cybersecurity
Public consultations have opened for the below two documents: → Commission Implementing Regulation concerning reprocessing of single-use medical devices (rules and common specifications) until 20th…