Common specifications in the DM industry   Draft after draft, the device industry was no longer waiting for them; but…

THE LABYRINTH OF CLINICAL EVALUATION If the clinical evaluation had already taken off with MEDDEV 2.7.1, rev. 4, the European…

MDR AND STANDARDS; a though nut to crack In one week, MDR 2017/745, dear to everyone’s heart, will enter into force.…

FIRST MDCG GUIDE FOR THE YEAR 2021 (MDCG 2021-1) HAS ARRIVED ! EUDAMED, the European database intended to gather all…

ISO 10993-23: 2021 The wind is blowing on the normative landscape of biocompatibility. After the publication of ISO 10993-18: 2020…

EUROPEAN DATABASE ON MEDICAL DEVICES (EUDAMED) The European Commission has published in August that the module of the registration of the actors…

EVIDENCE BASED MEDICINE With the COVID-19 pandemic, the investigative clinical studies have been launched in the spotlight. The discussions, experts…

MY HEALTH 2022 Reminder : the decrees implementing the law «Ma santé 2022» (My Health 2022) will enter into force…

ANTI-GIFT LAW « My Health 2020 » law provided for an overhaul of the relationship between persons manufacturing or marketing healthcare products…

MDCG NEWS The Medical Device Coordination Group (MDCG) is very active in May 2020 with the publication of MDCG 2020-10…

4 NEW GUIDELINES PUBLISHED BY THE MDCG The MDCG « Medical Device Coordination Group » published on 20 April 2020 a series…

European regulation (EU) 2020/561 The European regulation (EU) 2020/561 dated 23 April 2020 amending the postponement of European Regulation 2017/745…

The postponement of European Regulation 2017/745 (EU) enforcement was voted on 17 April 2020 by the European Parliament. It has…