The timetable for these products will be adjusted:
"[…] a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues […]“
This gives manucfacturers of class I products further four years to meet MDR requirements.
Changes and additions can also be found in the following sections:
Medical device manufacturers will find all changes in detail in this document, the English version starts on page 43.