May 09, 2022
MDCG 2022-5 and the concept of “liable to act on the body” - Much ado about nothing?
The guidance on the borderline between medical devices and medicinal products is now released in its final version. Its publication is very welcome as it replaces the old “borderline manual”, formally only applicable to MDD but practically, lacking alternatives, still used to unravel complex MDR classification issues.
Medical Device Regulations