Knowledge Center

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 (...)

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

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

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

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

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