The Medical Device Regulation replaced the earlier directives and considerably tightened requirements on clinical evaluation, post-market surveillance and notified bodies. Many existing devices benefit from extended transition periods until the end of 2027 or 2028, depending on class.
Software as a medical device
Software is a medical device if it has a medical purpose, such as diagnosis, monitoring or therapy support. Under Rule 11, much such software is classified at least as class IIa, which requires a notified body. Health apps without a medical purpose, for general wellbeing for example, are not covered.
Swiss manufacturers
Since May 2021, the mutual recognition agreement between Switzerland and the EU has not been updated for medical devices. Swiss manufacturers need an authorised representative in the EU for the EU market, and Switzerland in turn requires a Swiss authorised representative for foreign manufacturers.
Relation to other rules
Medical devices under the MDR are excluded from the Cyber Resilience Act, because the MDR contains its own cybersecurity requirements. Health data is additionally subject to data protection under Article 9 GDPR. Approval questions belong to specialised regulatory affairs professionals; a compliance assessment maps the remaining duties.