Liability Information
MediMark Europe
11 rue Emile Zola
38100 Grenoble
France
Phone: +33 (0)4 76 86 43 22
President: René Clément
Design and implementation of the website:
ASIR. 2 Allée de l’Atrium. 38940 Claix. France. www.asir.fr Tel. +33 (0)4 58 00 15 85
MediMark Europe maintains this web site to enhance client access to information about the regulation concerning Medical Devices and In Vitro Diagnostic Medical Devices. Our objective is to keep this (…)
Most recent articles
-
Imprint
7 October, by Rene Clement -
Contact us
6 October, by Rene ClementGDPR
Sending the contact form implies your acceptance of the Privacy Policy of MediMark Europe that you can find at the bottom of this page. MEDIMARK® EUROPE SARL
European Headquarter operations
11, rue Emile Zola - BP 2332, 38033 Grenoble Cedex 2 - FRANCE Phone: +33 (0)4 76 86 43 22 Fax: +33 (0)4 76 17 19 82 info@medimark-europe.com Contact us by email or receiving a proposal estimate
< -
Privacy Policy
3 October, by Rene ClementPrivacy Policy
Welcome to the MediMark Europe website. We appreciate your interest in our company. Protection of the personal data you entrust to us is a priority and we want you to feel safe and secure when you visit our website or use our online offers.
In order to fulfill our information obligation towards our clients as per Art. 12, 13 of the General Data Protection Regulation (GDPR), we subsequently present you our information on data protection:
Who is responsible for data (…) -
2024-07-24 New Annexes A to G for MIR Form updated 9 May 2024
30 July, by Rene Clement2024-07-24 New Annexes A to G for MIR Form updated 9 May 2024
Link:
https://www.imdrf.org/documents/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes
IMDRF Adverse Event Terminology Web Browser
The web browser for IMDRF AE terms ensures user-friendly searching and hence better and more adequate use of terms by reporters/regulators.
• Annex A: Medical Device Problem
• Annex B: Cause Investigation - Type of Investigation
• Annex C: Cause (…) -
Welcome
17 July, by Rene ClementCookie Policy : MediMark Europe’s Website uses cookies to assist with navigation and your ability to provide feedback and analyze your use of our services and assist with our marketing efforts and provide informational content from third parties. First Cookies used are “Function Cookies”, always active ones, necessary for the website to function. They cannot be switched off in our systems but are only set in response to actions made by you such as your logging in or filling in forms. You (…)
-
2024-01-23: Proposal from the European Commission for IVDR extension of the transitional period & MDR-IVDR new shorter mandatory dates for EUDAMED
24 January, by Rene ClementThe European Commission today, (January 23, 2024) published a proposal (See attached the proposal, press release, Q&A).
This proposal provides:
1) An extension of 2.5 years under conditions of the transition period for devices benefiting from transitional provisions. 2) An obligation to notify authorities, the supply chain and customers of the discontinuation of the marketing of a device at least six months in advance when such interruption could result in serious harm to patients (…) -
EU: REACH - ANNEX XVII RESTRICTION ON MICROPLASTICS WAS PUBLISHED ON SEPTEMBER 27, 2023
21 December 2023, by Rene ClementWHAT ARE THE IMPACTS FOR IVDs and MDs ?
On 27 September 2023, the European Union’s Official Journal (OJEU) published Regulation (EU) 2023/2055, introducing a new restriction on microplastics under Annex XVII to REACH regulation which will enter into force from 17 October 2023 with some exemptions and with transition period for some items.
The new restriction aims to reduce emission of intentional microplastics from the products. It covers all synthetic polymer particles below five (…) -
Regulation (EU) 2023/2713 of 5 December 2023 designating the European Union reference laboratories
7 December 2023, by Rene ClementThe European Commission yesterday published Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating the European Union reference laboratories in the field of in vitro diagnostic medical devices
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202302713
With this publication, the European Commission officially designates selected EU reference laboratories in the following areas: hepatitis and retroviruses, herpesviruses, bacterial agents and respiratory (…) -
MediMark Europe Quality Policy
14 November 2023, by Rene ClementManagement declaration
Management declaration
« The ‘Authorized Representative’ is defined as any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the MDR & IVDR Regulations ».
MediMark® Europe was the first European Company of Regulatory Affairs which has set up, in 1995, (…) -
Historic, references, key people
4 September 2023, by Rene ClementMEDIMARK® EUROPE has been created early 1995 by René Clement in order to fulfil the need for non- European Manufacturers of Medical Devices to designate an official European Authorized Representative such as requested by the MD Directive and reinforced by the IVD Directive.
The focus on this activity has allowed MediMark® Europe with the help of Competent Authorities, to build tools and procedures which are recognized as the gold standard for product notification, incident reporting and (…)