Laws and regulations

To bring a novel application or invention into clinical practice, it will have to comply with different laws and regulations. Laws and regulations can apply to the research itself, for example when patients are included, but also to the final product.

The ELSI service desk can help you with information about the laws and regulations that apply to your research, development and implementation.

Examples of important laws and regulations that may apply to your development include:

WMO - Research on/with patients

If you are performing research in which patients are subjected to procedures, you may have to deal with "Wet medisch-wetenschappelijk onderzoek met mensen (WMO)". The website of the CCMO describes when and how the law is applied (in Dutch).

GDPR/ AVG - Research making use of personal and/or medical data (including sequencing data)

Since 2018 a European law about the use of personal data is in place, called General Data Protection Regulation (GDPR), or in Dutch "Algemene verordening gegevensbescherming (AVG)". This law lays down rules relating to the protection of natural persons with regard to the processing of personal data. this includes medical data, and any data that can be traced back to a specific person. this latter also includes for example DNA sequencing data. The GDPR places a great responsibility at organisations using personal data and there are high fines when responsible parties do not commit to the law.

Because the GDPR/AVG is relatively new, there is still some variety in how the law is applied in different institutions, and different countries. Nevertheless, it is important that you adhere to the regulations. To find out if and how the rules apply to you, you can:

Contact your local policy makers and legal department to learn about your institutions execution of the GDPR.

Contact ELSI servicedesk.

Checkout the website of the Autoriteit persoons gegevens for some general information and tools to help you get started.

MDR/IVDR certification of medical equipment and in vitro diagnostics

Any novel medical device, such as machinery or software, has to be certified according to the Medical device Regulation (MDR). In vitro diagnostic application will have to comply to In Vitro Diagnostic Regulations (IVDR). The MDR/IVDR regulations replace the CE marking. The MDR/IVDR are novel and not all parts of its execution have fully crystallized. For help on this subject you can contact ELSI service desk. Information to help you get started can be found here.