Questions and Answers document updated version has been released on 21.10.2019 by the European Medicines Agency (EMA). Notified bodies should seek authorisation to the EMA…
Updated version of MDCG Q&A Document released in June 2019
The MDCG has updated the useful Questions & Answers document focusing on the Notified Bodies’ requirements under MDR and IVDR. It widens the scope of…
SOFTWARE: Qualification and classification
On the 11th of October 2019, the MDCG issued a Guidance on the qualification and classification of software under the MDR and IVDR. The MDCG…
NB designation process – Final Assessment Form
You can have a look at the final assessment form for the designation of a Notified Body under MDR and IVDR, used by the Designating…
DEKRA is the first NB accredited for the IVDR
This morning, the European Commission updated the NANDO database, by adding the first Notified Body that was designated under the Regulation (EU) 2017/746 on in…
MDCG: MDR Transitional regime
The MDCG published on Friday a guidance document, where it further clarified Article 120 (2), (3) of the MDR – Transitional provisions. These provisions allow…
Summary of safety and clinical performance: Content, Template by MDCG
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…