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Latest update : 25.09.2020


The main changes introduced by "MDSAP AU P0002.005 Audit Approach" document | 25.09.2020

On Sept. 3, 2020 the MDSAP consortium has published a new document "MDSAP AU P0002.005 Audit Approach". This document replaces the former "MDSAP Audit Model" and "MDSAP Companion Document" by a unique combined one.

The new MDSAP audit approach document became effective immediately, with a transitional period until September 30, 2020 for audits already started on the date of publication of the document, allowing Auditing Organizations to train their auditors accordingly.

The main changes introduced are:

  • A Statement was added to allow some flexibility to the audit sequence, subject to justification
  • Clarified expectations on critical suppliers and outsourced processes
  • Corrections were made on the duration for Brazilian "registration" and "notification"
  • In the process "Measuring, Analysis and Improvement" the Task 14 (Evaluation of Complaints for Adverse Event Reporting) and Task 15 (Evaluation of Quality Problems for Advisory Notices) have been rewritten to eliminate perceived redundancy with tasks 1 and 2 of the “Medical Device Adverse Events and Advisory Notices Reporting” process.
  • Reinforcement of requirements for Sterile Medical Devices during the audit in Annex 2
  • New Annex 3 as a reference guide on declarations’ deadlines for adverse events and advisory notices to authorities
  • New Annex 4 to specify the contract requirements with a specific focus on the contract between a manufacturer and the Australian sponsor


GMED designated under Regulation (EU) 2017/745 on medical devices | 08.07.2020

GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency for Medicines and Health Products Safety (ANSM).

Equipped with this designation since July 8, 2020 GMED has mobilized its teams to offer manufacturers with certification services according to the Regulation (EU) 2017/745 for a field of medical device categories among the broadest *.

Simultaneously, during the transition period, GMED gathers all the necessary resources to allow manufacturers to maintain, in a suitable manner, on the European market, the medical devices covered by certificates of conformity under the Directives 90/385/EEC and 93/42/EEC.

In deployment of its development strategy, GMED consolidates its support methodology for each certification project to provide a service of Excellency to its current and future customers.

To complement its MDR designation approach, GMED is determined to succeed in the best possible timeframe, its designation under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

GMED and all of its teams remain fully invested for the transition to the new Regulations to be a success for all.

* The scope of GMED’s designation can be searched on the European Commission's information system, New Approach Notified and Designated Organizations: NANDO

GMED’s business continuity plan in the context of the COVID-19 health crisis | 14.05.2020

As part of the deconfinement plan announced by the Government on April 28, GMED implemented a business continuity plan, and health and safety measures to protect its employees, partners and customers in the context of the coronavirus health crisis (COVID-19).

At the LNE Group level, a coordination and monitoring Unit including GMED and GMED North America. will regularly reassess the actions and provisions according to national and international health status evolution, and the French authorities’ recommendations.

We inform you that GMED sites in Paris and Saint Etienne reopened on May 11th during normal working hours. To ensure the safety of all, their access is subject to reinforced rules and instructions.
In remote and / or on site, our employees remain engaged to ensure the continuity of our certification activities.
In this first phase of deconfinement, it remains appropriate to send your documents in a digital version and hold meetings with our teams by videoconference.

Remote audits and electronic signature are all new provisions successfully implemented during this containment period. In fact, GMED is working to maintain some of these achievements beyond the COVID-19 crisis.
Regarding your audits and assessments as part of your certification, GMED maintains its current remote audit provisions. We plan, starting June 2020, to gradually resume our on-site audits in France, provided all applicable health and safety requirements are met.

Your dedicated Certification Project Manager will inform you of any specific information relating to your audit or assessment.


MDSAP program is now utilized by 2 other countries: South Korea and Argentina | 03.04.2020

South Korea (Ministry of Food and Drug Safety) first and now Argentina (ANMAT) have very recently joined the MDSAP program as affiliated members.

Although not an observer, like the WHO or the European Union, nor a member of the consortium of regulatory authorities at the initiative of the program (Regulatory Authorities Consortium /RAC = Australia, Brazil, Canada, Japan, United States), this special status, created in 2019, define a framework within which a country can utilize the MDSAP audit reports or certificates to evaluate a medical device manufacturer’s quality management system under its own regulation. This is a very positive perspective for companies certified by GMED and more generally for all of the more 5,000 sites audited under the MDSAP program.

After the approval of their formal application, MDSAP Affiliated Members shall demonstrate an understanding of the program MDSAP by completing the on-line training materials and by staying up to date with the MDSAP policy documents. They have to report annually the utilization of MDSAP report(s) and/or MDSAP certificate(s) to the RAC. MDSAP Affiliated Members will be invited to attend sessions of the annual MDSAP Forum open to medical device industry.

MDSAP Affiliated Members will be regularly granted access to an extract of the MDSAP master list (the manufacturer’s information, the manufacturing site, audit dates and the corresponding recognized auditing organization/AO). As they will not have access to the MDSAP database on the Regulatory Exchange Platform – (REPs) hosted on the secured web portal, they will contact manufacturers in order to receive MDSAP audit report(s) and/or MDSAP certificate(s).


GMED’S business continuity plan in the context of the COVID-19 health crisis

As the COVID-19 crisis evolves and is now officially a pandemic, we are taking additional security measures to protect our employees, partners and customers. We have implemented a business continuity plan that ensures the health and safety of our employees, their families and the customers we serve, while maintaining uninterrupted service. We are committed to our customers throughout this crisis.

GMED has asked its employees around the world to temporarily work remotely, starting today. Our objective throughout our preparations for telework has been to set up a smooth and efficient system to allow all employees to work in the best conditions and ensure the continuity of the certification activities with provisions adapted to the situation.

All activities and communications continue. GMED employees can communicate with their customers remotely. Our organization is committed to providing the best level of response and service to our customers in the current environment.

We are now using videoconferencing to facilitate meetings and have ensured that all GMED employees are equipped. You will exchange with your usual contacts by email (in priority) and by phone, they are able to meet your needs without interruption.

We make every effort to ensure that this health event has the lowest possible impact on your certification. Any specific information relating to your audit or evaluation will be communicated by your dedicated certification project manager.

We thank you for your understanding in this unprecedented situation that we all face.


Information related to the COVID-19 coronavirus health crisis

GMED implemented exceptional provisions to ensure the protection of its employees, suppliers and customers in the context of the health crisis linked to the coronavirus (COVID-19).

A coordination and monitoring unit has been set up at the LNE Group level, including GMED and GMED NA. The actions and measures to be taken are regularly reassessed according to the evolution of the international health situation and the recommendations of the French authorities.

The rules for individual protection concerning epidemiological contagion on the basis of recommendations issued by the French Ministry of Solidarity and Health are reminded to all our employees and suppliers.

All trips to areas at risk established by the French authorities are suspended. This list of areas at risk is regularly updated based on information issued by the Government and the French Ministry of Europe and Foreign Affairs.

In this context, the exceptional arrangements decided may have an impact on the audits planned for the next two months with GMED.

GMED studies each situation on a case-by-case basis and may have to make transitional arrangements (documentary audit and on-site audit planned later on, remote audit, etc.) according to the rules set out in the International Accreditation document. Forum, governing crisis situations: document IAF ID3 - Informative Document For Management of Extraordinary Events or Circomstances Affecting Abs, CABs and Certified Organizations.

If necessary, GMED invites you to contact without delay, by e-mail, your Certification Project Manager in order to inform us about your specific situation to be assessed, and send a copy to the GMED operations management at the following address (please use the keyword COVID-19 in the subject of your email).

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