Getting your Medical Device to market quickly without sacrificing quality is critical. Inefficiencies in the process can slow down your device’s market access.
Get your Medical Device into Europe & Choose our ExpressCert Program
You need a Certification Body that is an Expert at both efficiency and your device, one that will help you protect your investment. GMED performs CE Marking assessment in accordance with the applicable European Medical Device Directives:
A Faster Standard Review Time
GMED’s Expertise in efficiency means that our standard assessment time is in line with the needs of the Medical Deviceindustry.
|Assessment for:||30 Working days|
|Quality system according to the provisions of the European directives (CE Marking)||From the last day of the on-site Audit|
|The Medical Device according to the Essential requirements of the CE Marking (Design Dossier - Technical Documentation)||As soon as we receive your Design Dossier/Technical Documentation|
A Faster Standard Review Time
Need to Get your Medical Devices into Europe Fast? Choose our ExpressCert Program!
Can GMED Really
Assess My Device in 30
Through the ExpressCert Program, GMED coordinates and ensures that resources are available to devote time to your device assessment. Before getting started, we will perform a preliminary review to determine if we need more information. The clock starts as soon as we receive the last piece of information needed from you or at the end of the audit! As long as there are no major issues or non-conformities, within those 30 working days, you will receive the opinion of our committee.*
* Our ability to accommodate ExpressCert certification depends on your capacity and on how quickly you can provide us with the required information needed to assess the regulatory compliance of your device. Note that a positive outcome of our assessments (issuance of a certificate) within 30 working days cannot be guaranteed.
** Please note that the ExpressCert service does not guarantee a positive result of our assessments (issuance of a certificate) within 30 working days and doesn’t modify or accelerate the duration of our evaluations (such as audit duration or the time required to assess the conformity of the product).
Library of regulatory updates, certification information, and other updates in the medical device field.
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 (...)
European Commission publication on EUDAMED and the module on economic actors’...
The European Commission has recently published on its website information dedicated to EUDAMED and more specifically information related to the (...)
The main changes introduced by the “MDSAP AU P0002.005 Audit Approach”...
On Sept. 3, 2020 the MDSAP consortium has published a new document “MDSAP AU P0002.005 Audit Approach”. This document replaces the (...)
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 (...)
The Implementing Regulation (EU) 2020/1207 of the European Commission of August...
The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020, published in the Official Journal, lays down (...)
MDCG Position paper on the use of the EUDAMED actor registration...
The Medical Devices Coordination Group (MDCG) has just published a position document on the use of the EUDAMED actor registration (...)
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 (...)
Commission guidance for the medical devices expert panels on the consistent...
The European Commission has just published in its Official Journal a text named “Commission guidance for the medical devices expert (...)
View all our technical, regulatory and normative information including guides, webinars, news…
European Medical Devices Regulation (EU) 2017/745
Leading Certification Organization & Notified Body (CE0459)
GMED’s success and performance rely on a strong and dedicated team of individuals, trained to the highest level of assessment and auditing methods, to provide the best in medical device certification services: