Knowledge Center

View all our technical, regulatory and normative information including guides, webinars, news...

Clear search
News

Guidance MDCG on classification for IVD MD under Regulation (EU) 2017/746

The Medical Devices Coordination Group (MDCG) has published a Guidance document MDCG 2020-16 on Classification Rules for in vitro Diagnostic (...)

Learn more
News

European Commission publication on EUDAMED and the module on economic actors’ registration

The European Commission has recently published on its website information dedicated to EUDAMED and more specifically information related to the (...)

Learn more
News

The main changes introduced by the “MDSAP AU P0002.005 Audit Approach” document

On Sept. 3, 2020 the MDSAP consortium has published a new document “MDSAP AU P0002.005 Audit Approach”. This document replaces the (...)

Learn more
Guides

Biological assessment of medical devices according to the ISO 10993-1 standard

The GMED teams have prepared this document in an aim to guide the medical device manufacturers in the presentation and (...)

Learn more
News

The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020

The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020, published in the Official Journal, lays down (...)

Learn more
News

MDCG Position paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

The Medical Devices Coordination Group (MDCG) has just published a position document on the use of the EUDAMED actor registration (...)

Learn more
News

European Commission updated FAQs on Unique Device Identification (UDI)

The European Commission has just published an updated FAQ covering 16 key questions regarding the Unique Identification System (UDI) under (...)

Learn more
News

Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure

The European Commission has just published in its Official Journal a text named “Commission guidance for the medical devices expert (...)

Learn more
Guides

Medical Devices Clinical Evaluation – Summary of Safety and Clinical Performance (SSCP) – Regulation (EU) 2017/745

It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with the (...)

Learn more
News

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

GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency (...)

Learn more
Guides

Application request for CE marking certification – Regulation (EU) 2017/745

This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) (...)

Learn more
Guides

Codes assignment referred to in the implementing Regulation 2017/2185 in the context of a request for certification according to the Regulation (EU) 2017/745

Commission Implementing Regulation 2017/2185 establishes the codes for the definition of notified bodies’ scope of designation in medical devices under (...)

Learn more
Guides

How to change your Notified Body to GMED in 8 steps

Within the constantly changing regulatory framework and in view of uncertainties regarding the future of certain notified bodies, more and (...)

Learn more
Webinars

Stepping into an MDSAP audit

The Pilot version of MDSAP started on January 2014 and was converted through a transitional period lasting until the launch (...)

Watch
Webinars

CE Marking of Medical Devices: Elements to be provided during the Evaluation of the Technical Documentation

In the context of EC type and EC Design examinations, LNE / G-MED provides Medical Device Manufacturers with a list (...)

Watch
Webinars

IVD European Regulation: how QMS requirements interacts with ISO 13485:2016

Medical Device Manufacturers went through significant changes in the last couple of years: The publication of ISO 13485:2016 on February (...)

Watch
Webinars

Medical Device Usability: Highlights of European Regulations and the Latest Standards

Each year, medical device incidents due to use/user errors caused mainly by poor user interface design are reported, some can (...)

Watch
Webinars

Post-Market Surveillance requirements under the new European Medical Device Regulations

In the current Medical Device Directives, Post Market Surveillance is defined in Chapter I, Article 2, (40a), as the action (...)

Watch
Webinars

Biocompatibility: How to demonstrate the control of the biological risk according to the NF EN ISO 10993-1 (2010) standard?

The biocompatibility is a preclinical aspect important for any medical device in contact with the human body. The subject is (...)

Watch
Webinars

Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives

The publication of ISO 13485:2016 in March last year reinforced the notion of control of supply chain for Medical Device (...)

Watch
Webinars

E-health technologies in Medical Devices: identification of the key development milestones and regulatory constraints

When developing E-healthcare technologies with the objective to market them in Europe, it is key to well understand the regulatory (...)

Watch
Webinars

Medical Device & IVD regulations, impacts for MD manufacturers

The origin of the proposed regulations dates back to 2008: The Medical Device Regulation and the In Vitro Diagnostics Regulation were initially proposed in (...)

Watch
Webinars

Notification of changes: How, what and when to communicate with your Notified Body

Innovation triggers changes. The Medical Device Industry more than any other industry, follows the course of demands and needs that see thousands (...)

Watch
Webinars

Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers

The certification audit is a major step for a Medical Device manufacturer to access the market. In this webinar, we will go (...)

Watch
Webinars

MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)

In June 2016, the MEDDEV 2.7.1 rev 4, the European guidance on the clinical evaluation of medical devices (MD) was published. The issuance (...)

Watch
Webinars

Clinical and Performance evidence requirements in the future EU IVD Regulation

The regulatory landscape for In Vitro Diagnostics (IVDs) in Europe is expected to go through some significant changes in the (...)

Watch
Webinars

Impact of Critical Suppliers and Subcontractors on Medical Device Market Approvals

There is a growing need in the current global economy to outsource with no foreseeable turning back. Medical Device and (...)

Watch
Webinars

Evolution of ISO 13485:2016 and ISO 9001:2015 standards

With over one million certified companies over the world, the international quality management systems standards ISO 9001 and ISO 13485 (...)

Watch
Webinars

Embedded Software in Medical Device: Common Regulatory and Quality pitfalls

Software nowadays is a key component in healthcare industry. Medical device software, embedded in medical devices, can be found in (...)

Watch
Webinars

Controlling Critical Subcontractors in 2014

Recent regulatory evolutions in the EU have prompted manufacturers and notified bodies to take second looks at how medical device (...)

Watch
By continuing to browse this site, you accept the terms of our personal data privacy policy.