Updating of the evaluation of clinical data according to the requirements of Regulation 2017/74518 Jun. Read more
Coronavirus Information – COVID-1920 Mar. Read more
Deadline for class 1 medical devices that change class with Regulation 2017/74530 Nov. Read more
Guide relative to the «Summary of Safety and Clinical PErformance» (SSCP) – Manufacturers’ Guide – August 1922 Oct.
SUBJECT: 2019-09 – Guide relating to the “Summary of Safety and Clinical Performance” (SSCP) – Manufacturers’ Guide – August 19Read more
Isocèle Conseil is looking for experienced consultants27 Sep.
Isocèle Conseil is looking for experienced consultants to enhance the team.Read more
MDCG 2019-8 Guide – Directives relating to implant cards in accordance with article 18 of the MDR22 Jul.
This document has been approved by the Medical Device Coordination Group (MDCG) created by article 103 of EU Regulation 2017/745.Read more
MDCG 2019-7 Guide – Directives relating to article 15 of the MDR and IVDMDR15 Jul.
SUBJECT: MDCG Guide 2019-7 – Directives relating to Article 15 of the MDR and IVDMDR (In-Vitro Diagnostic Medical Device Regulations) regarding the “Person Responsible for Regulatory Compliance” (PRRC)Read more
Regulatory Information11 Jun.
TGA Australia – Requirements relating to brochures and implant cards for implantable devices that are and will be available on the market.Read more
Vigilance News11 Jun.
The Post-Market Surveillance and Vigilance Working Group (Sub-Group of the MDCG) has issued an addendum to the MEDDEV Guide 2.12-1 Ver. 8 for compliance with the regulation.
This guide must be used in conjunction with the MEDDEV Guide for vigilance.Read more
News 06/05/20196 May.
Draft Implementing Regulation relating to the common features and application of classification rules for non-medical devices.Read more
News 16/04/201916 Apr.
MD-IVDMD Regulations / News on the EUDAMED databaseRead more
Analysis of ISO/DIS 14155 standard17 Jan.
Analysis of ISO/DIS 14155 standard (currently being drawn up) – Clinical investigation of medical devices for human subjects — Good clinical practicesRead more