Like any product placed on the market, medical devices must also comply with laws and regulations. It can be quite difficult to find out exactly which laws and regulations the product must comply with. Unfortunately, the Notified Body is not going to help you with this either. You have to do your own research into the legislation that applies. In this Q&A you can find information about building up knowledge internally. For finding help from external partners see [see also: Where can I find help?].
Where to find more information?
On the internet there is a lot of information about setting up a quality management system, drawing up the technical documentation or interpreting other legal requirements. There are also templates that can be used to create these documents. In particular, guidance documents provided by Notified Bodies or the European Commission contain useful information to help understand the legislation (Guidance – MDCG endorsed documents and other guidance (europa.eu)). Do note that a lot of information is generalized, since the requirements have been drawn up for a very wide range of Medical Devices. It does give direction to how to comply with the MDR, the QMS or the TCD and how to set this up.
Where to find education?
Following a training on standards can be a helpful method to get you started on the topic. Think about ISO13485, ISO27001 (for example by the Nederlandse Normalisatie Instituut, NEN), IEC60601 and IEC62304.
Where to find events?
Events organized to inform about the MDR exist at regional (by e.g. d-Health, HTRIC, Life Cooperative), national (for e.g. the NEN, professional groups such as BMTZ) and European level (by e.g. MedTech Europe, RASP). Below are two immediate tips:
- Watch the records of DASH Sparkle Event: Software as a Medical Device – YouTube
- Sign up for the newsletter and events of the official professional group of QA and QA called RAPS (Regulatory Affairs Professionals Society) the Dutch section. You can subscribe via email@example.com.