CE marking of Medical Devices
Medical Devices that are placed on the market in the EU must comply with the European Regulations and must be CE marked.
There are more than 500.000 types of medical devices currently available. They range from everyday products such as sticking plasters, contact lenses and surgical masks to MRI machines and hip replacements. In the EU the smooth functioning of internal market, together with patient safety, has been enforced with common regulatory framework. Medical devices are regulated by the Regulation (EU) 2017/745 on medical devices (MDR).
On this page you will find information on the basic requirements and legislation of medical device in the EU, and the services that SGS Fimko as a Notified Body can offer.
Conformity assessment by a notified body
When a medical device is of higher risk class than class I, conformity to regulations must be assessed by a Notified Body. After MDR’s Date of Application, from 26 May 2021 the assessment must take place according to the rules of MDR.
SGS Fimko Ltd is Notified Body 0598 that has been designated according to the MDR. Please see the SGS Fimko’s scope of designation from the NANDO database. Because each type of equipment requires specific competence from the Notified Body, SGS Fimko has focus on active devices, including standalone software application. We are committed to provide the services professionally and impartially. All of our management has signed a Declaration of Impartiality.
Depending on the risk class, there are several conformity assessment routes available. We have prepared an infograph on how conformity assessment procedures can be arranged according to MDR Article 52 and what is required in preparing for the conformity assessment.
Our recommendation is to follow the Annex IX route – Conformity Assessment Base on a QMS and on Assessment of Technical Documentation – because MDR makes the QMS with minimum requirements compulsory for a medical device company.
Certification process with SGS Fimko
SGS Fimko Ltd’s Notified Body 0598 will be able to certify medical devices within the designated scope. The process, starting from application review will include many critical steps. In the Downloads section below you will find our brochure Your Certification Process Explained which will give you a good summary on what is required.
When you plan to have your medical device certified, please contact our email address nbmed.fimko@sgs.com for application material and further information.
Because medical devices and manufacturers are different, we are not able to give you an estimate of turnaround time or cost of the certification project without an application review. You may however get an idea of the costs involved from our MDR Standard Fees list.
Additional information
As legal text the MDR (EU) 2017/745 is not always easy to interpret. Because of that the Medical Devices Coordination Group is publishing a series of MDCG Guidance Documents.
They include practical how-to guidance to variable topics, from EUDAMED to interpretation of significant changes. While the MDCG documents are not legally binding, they are highly recommended reading and will be applied by Notified Bodies.
Downloads
Conformity Assessment Routes
An infograph illustrating several conformity assessment routes that are available
Declaration of Impartiality
SGS is committed to impartiality and to avoiding conflict of interest when performing certification of quality management systems and products.
Gap analysis
A non-exhaustive list of MDR requirements that are not covered by complying with the EN ISO 13485:2016 standard.
Your Certification Process Explained
This important document outlines the audit process for MDR