Les actualités

Isocèle Conseil is looking for experienced consultants

Isocèle Conseil is looking for experienced consultants to enhance the team.

Updating of the evaluation of clinical data according to the requirements of Regulation 2017/745

Coronavirus Information – COVID-19

Deadline for class 1 medical devices that change class with Regulation 2017/745

Guide relative to the «Summary of Safety and Clinical PErformance» (SSCP) – Manufacturers’ Guide – August 19

SUBJECT: 2019-09 – Guide relating to the “Summary of Safety and Clinical Performance” (SSCP) – Manufacturers’ Guide – August 19

MDCG 2019-8 Guide – Directives relating to implant cards in accordance with article 18 of the MDR

This document has been approved by the Medical Device Coordination Group (MDCG) created by article 103 of EU Regulation 2017/745.

MDCG 2019-7 Guide – Directives relating to article 15 of the MDR and IVDMDR

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)

Regulatory Information

TGA Australia – Requirements relating to brochures and implant cards for implantable devices that are and will be available on the market.

Vigilance News

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.

News 06/05/2019

Draft Implementing Regulation relating to the common features and application of classification rules for non-medical devices.

News 16/04/2019

MD-IVDMD Regulations / News on the EUDAMED database

Analysis of ISO/DIS 14155 standard

Analysis of ISO/DIS 14155 standard (currently being drawn up) – Clinical investigation of medical devices for human subjects — Good clinical practices