Our news

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

18 Jun. Read more

Coronavirus Information – COVID-19

20 Mar. Read more

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

30 Nov. Read more

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

22 Oct.

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

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Isocèle Conseil is looking for experienced consultants

27 Sep.

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

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

22 Jul.

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

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

15 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)

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Regulatory Information

11 Jun.

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

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Vigilance News

11 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.

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News 06/05/2019

6 May.

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

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News 16/04/2019

16 Apr.

MD-IVDMD Regulations / News on the EUDAMED database

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Analysis of ISO/DIS 14155 standard

17 Jan.

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

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