Welcome to our Library of Regulatory, Certification Information and Updates in the Medical Device Area
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 8th 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*.
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.
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 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 North America. The actions and measures to be taken are regularly reassessed according to the evolution of the international health situation.
In an effort, to mitigate, potential cybersecurity threats due to the increasing levels of interconnectedness and data exchange between medical devices— Health Canada has released a guidance document on “pre-market requirements for medical device cybersecurity.”
The guidance document defines cybersecurity as, “the body of technologies, processes, practices, responses and mitigation measures designed to protect a medical device against unauthorized access, modification, misuse, or denial-or-use, and against the unauthorized use of information stored, accessed, or transferred to or from a medical device.”
On June 6th, 2019 the European Union released a document, with a note from the Irish and German Delegations on the implementation of Regulation (EU) 2017/745 on medical devices. The document addresses the increased number of discussions regarding the challenges and concerns facing stakeholders (manufacturers, notified bodies, authorized representatives, distributors, competent authorities, European Commission) in the medical device sector to implement the new Regulations in a timely and effective manner.
The European Union has constructed an excel document detailing essential information regarding the MDR/IVDR implementation rolling plan. The document is organized into two different sections: implementing acts and other actions/initiatives. This document is intended to coexist with the “MDR/IVDR roadmap,” which was created by the Competent Authorities for Medical Devices project (CAMD) In cooperation with the EU Commission which involves a much more detailed synopsis of all the initiatives and guidance documents expected to be undertaken during the period of transition by the Commission and the National Competent Authorities.
The International Medical Device Regulators Forum (IMDRF) held the fifteenth meeting of the Management Committee (MC) in Moscow, Russia on March 18th -21st, 2019. The MC consisted of regulatory leaders from around the world such as: Australia, Brazil, Canada, China, the European Union (EU), Japan, Russia, Singapore, South Korea, and the USA.
On March 13th, 2019 the Council of the European Union released two corrigenda documents, pertaining to the Regulation (EU) 2017/745 on Medical Devices and the (EU) 2017/746 on In Vitro Diagnostics Medical Devices. In an effort to rectify mistakes and discrepancies within the new European Regulatory framework, Member States were allowed to send comments and suggestions up until March 20th of this year. Then, on May 5th,2019 the official documents for the (EU) MDR 2017/745 and IVDR 2017/746 corrigenda were released by the Official Journal of the European Union.
The European Medicines Agency (EMA) plans on publishing a series of guidance documents to assist applicants in the medical device industry in preparation of the obligations delivered by the new Regulation (EU) 2017/745 on medical devices. This guidance document falls within the scope of EMA’s activities and should be read in alignment with the new Regulations (EU) 2017/745 on medical devices and (EU) 2017/746 on In Vitro Diagnostic medical devices.