Medical Devices Regulation (EU) 2017/745
All medical devices which are sold on the European market are required to bear the CE mark, except custom made devices. The CE mark indicates compliance with the applicable European legislation. The manufacturer of a medical device is responsible for the compliance of the medical device with the applicable European legislation.
Is your product a medical device?
Classification of medical devices
Not every medical device is the same and should therefore also not be treated as one entity. Therefore, the European Commission divided medical devices in different classes. The different classes are divided by the risk that they impose. A low risk medical device should go through a different, less complex, conformity assessment procedure than a high risk medical device. The risk classes are divided from low, class I, to high, class III.
The following risk classes are identified in accordance with the Medical Devices Regulation.
- Class I, e.g. simple wound dressing.
- Class I with a measuring function, e.g. non-active oral thermometer.
- Class I sterile, e.g. sterile simple wound dressing.
- Class IIa, e.g. condoms.
- Class IIb, e.g. medical devices for the cleaning of contact lenses.
- Class III, e.g. medical devices integrating medicinal products.
Conformity assessment procedure
In order to indicate compliance of the medical device with the applicable European legislation the correct conformity assessment procedure must be carried out. The conformity assessment procedure depends on the classification of the medical device. Figure 1 indicates the general conformity assessment procedure for medical devices, at the bottom of the page you can download your free conformity assessment procedure.
Manufacturers of medical device must ensure to have the required Technical Documentation in order regarding their medical device. The Technical Documentation entails all documentation which can be used to determine the compliance of the medical device with the applicable European legislation. The Technical Documentation entails minimally the following.
- Device description and specification (e.g. UDI, risk class, technical specifications etc.).
- Information regarding the labels and packaging.
- The instructions for use.
- Information regarding the manufacturing processes.
- Information regarding all production sites.
- Documentation demonstrating compliance with the general safety and performance requirements.
- The benefit-risk analysis.
- Documentation on all test results and analyses.
- Documentation on (pre-)clinical data.
Quality Management System
When medical devices are manufactured, they are often manufactured in series. In order to ensure the compliance of all the medical devices produced in series with the applicable European legislation, it is required for manufacturers to implement a Quality Management System (QMS). For instance in accordance with ISO 13485: 2016 see (https://certification-experts.com/iso-13485-2016-quality-system-medical-devices/ ) In this way the presumption of conformity is determined of all the medical devices produced in series.
Now we have covered the main topics of the MDR in four steps:
2. Conformity assessment procedure
3. Technical Documentation
This is a simplified guide to form the basic principles. Every medical device is different and in case of any question our experts are there to help you.
Download your conformity assessment procedure for free
- CE Marking
- Certification Experts
- Authorized Representative
- CE Declaration of Conformity
- Competent Body (Notified Body)
- Technical File
- Information on the Product
- USA compliance
- Self certification
- Export to China
- Summary Directives
- Medical Devices