What changed
The new version adds two recitals and one paragraph on substance-based medical devices and e-health applications, calling for their inclusion in the revised regulation to protect health data and foster innovation. #1#2
2 changes of substance. Each change below carries a one-line ✦ note from the same model. Written from the two texts only — read the highlighted passages before relying on it.
The changes to the text itself, in document order. Cover page, citations (“having regard to …”), standard resolution paragraphs and punctuation-only edits are left out — they are in “Show every difference”.
Change #1 Substance
Adds two recitals stating that the MDR's framework for substance-based devices aims to foster innovation, but national guidelines limit it, and that uncertified e-health apps may endanger health data.
O. whereas the innovative regulatory framework referring to substance-based medical devices, which was introduced by the MDR, is intended to encourage the development of therapies that act through non-pharmacological, non-immunological and non-metabolic means; whereas guidelines and decisions issued by national authorities set limits that classify products falling within the scope of the MDR under other regulatory categories, which goes against the EU legislator’s aim of fostering therapeutic innovation;
P. whereas e-health applications of which the purpose corresponds to the definition of medical devices are not currently certified, and therefore potentially endanger users’ health data;
Change #2 Substance
Adds a paragraph stressing the need to protect health data from e-health apps by explicitly including them in the revised MDR's scope with appropriate provisions.
9. Stresses the need to protect health data collected by e-health applications by expressly including these applications in the scope of the revised MDR and by laying down appropriate provisions on them;