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.
Questions & Answers from the European Commission on the European Medical...
The European Commission has just published a document gathering questions and answers on the EMDN. In accordance with Article 26 (...)
FAQ on the European Medical Device Nomenclature (EMDN)
The Medical Device Coordination Group (MDCG) has just published the MDCG 2021-12 FAQ on medical devices and in vitro diagnostic (...)
English version of the European Medical Device Nomenclature (EMDN)
A public consultation was organized by the European Commission on the European Nomenclature of MDs and IVD MDs (EMDN) within (...)
MDCG 2021-08 Guidance on Clinical Investigation Application and Notification Documents
Medical Devices Coordination Group (MDCG) has published a guidance on clinical investigation Application and Notification documents. The sponsor of a (...)
European Commission factsheet for manufacturers of implantable medical devices
Are you a manufacturer of implantable medical devices? Everything you need to know about the implant card and the information (...)
Introduction to the Regulation (EU) 2017/746
The Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices entered into force on May 26th, 2017 and we (...)
Launch of the Unique Device Identification (UDI) Helpdesk
On May 17, 2021, the European Commission launched a new helpdesk to assist economic operators in the implementing the obligations (...)
Harmonized European Standards under the European Regulations on MD and IVD...
On May 12, 2021, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) formally informed (...)
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: