There’s a bit of discussion in Elsmar about EU MDR Classification Rule 11. – Please explain MDR Rule 11 to me. Please feel free to…
Posts tagged as “MDR”
How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities
How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities
So after reviewing some concepts for a Clinical Evaluation training I gave this week, some people asked me about sources of literature on how to…
Novartis Inhaler is First Device to be Certified Under MDR
Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and…
GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or…
As reported previously, the Notified Body IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., designated by the Italian MOH, was included in Nando, confirming the…
This is a multi-part post. Why this? Part of the problem in understanding regulations and standards is the fact that they usually have requirement (the…
Designation from the Italian Ministry of Health (in Italian).
EU postmarket surveillance plans for medical devices
Notification of a Body in the framework of a technical harmonization directive – DEKRA Certification GmbH