SGS has several certification bodies according to the European Directives.
Notified Body MED
SGS offers you medical device certification in accordance with Regulation (EU) 2017/745 on medical devices (MDR), informally sometimes also called "CE certification". We provide our service with auditors from Germany and the European region. For your certification process, we support you with a professional and competent team located in Germany. Information about our certification range and the certification process can be found on this page.
Medical devices that are placed on the market in the EU must comply with the European regulations and must be CE marked.
There are currently more than 500,000 types of medical devices. They range from everyday products such as plasters, contact lenses and surgical masks to MRI machines and hip prostheses. In the EU, a common regulatory framework has ensured the smooth functioning of the internal market and patient safety. Medical devices are regulated by the Regulation (EU) 2017/745 on Medical Devices (MDR).
On this page you will find information about the basic requirements and legislation for medical devices in the EU, and the services that SGS can provide with its Notified Bodies NB 0598 / SGS Fimko and NB 1639 / SGS Belgium.
Conformity assessment by a Notified Body
If a medical device belongs to a higher risk class than Class I, its conformity with the regulations must be assessed by a Notified Body. After the date of application of the MDR, from May 26, 2021, the assessment must be carried out according to the MDR rules.
Depending on the risk class, there are several conformity assessment routes available. We have prepared an infographic 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
Beginning with an application review, the certification process includes many critical steps. In the Downloads section you will find our brochure "Your Certification Process Explained", which gives you a good overview of the required steps.
If you are planning to have your medical device certified, please feel free to contact us for further information and application documents.
Since medical devices and manufacturers vary greatly, we cannot give you an estimate of the turnaround time or cost for the certification project without an application review. However, you can use our MDR Standard Fees List to get an initial overview of the costs involved.
Additional information
As legal text, the Medical Devices Regulation (EU) 2017/745 (MDR) is not always easy to interpret. For that reason, the Medical Devices Coordination Group is publishing a series of MDCG Guidance Documents.
They include practical guidance on various topics, from EUDAMED to the interpretation of significant changes. Although the MDCG documents are not legally binding, they are highly recommended reading and are applied by Notified Bodies.
Downloads
- 10 Steps to CE Mark
Leaflet for the 10 steps required to CE mark a medical device (CE Marking). - Conformity Assessment Routes
An infographic illustrating several conformity assessment routes that are available. - MDR Standard Fees List
Costs involved with certification process. - Your Certification Process Explained
This important document outlines the audit process for Medical Device Certification according to the Medical Devices Regulation (EU) 2017/745 (MDR). - MDR Client-Technical Documentation Submission – checklist
Contact
Armin Hudetz
t: +49 89 78 74 75-133
f: +49 89 12 50 40 64-133
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Customer Service Team
t: +49 89 78 74 75-222
f: +49 89 12 50 40 64-100
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