You can read the full text of the
In March 2019 the EU Commission published a Corrigendum for the MDR (EU) 2017/745 including several corrections concerning all official languages.
(for Details see News-Blog " Corrigendum for the MDR published").
The Corrigendum introduces 14 corrections for the English version among these two corrections have a major impact to the Assessment of the Technical documentation of class IIa and IIb
(Details see News-Blog "Small Change - Hugh Impact").
For ease of navigation in the text of the MDR we prepared a Glossary / Index which guides you directly to the relevant articles of the (EU) 2017/475.
The medical device directive 93/42/EEC has been out on the field for almost a quarter of a century now. So the changes introduced by the European Medical Device Regulation are, of course, not insignificant.
The following sections will introduce you to a few changes in the current legal situation.
The minimum set of safety requirements for medical devices are listed in the EU Medical Devices regulation (EU) 2017/475 as Annex I under the heading "Essential safety and performance requirements".
As in the directive 93/42/EEC, Annex I consists of two parts:
Not only the number of requirements to be fulfilled has almost doubled, but also the requirements are clearly formulated. Therefore, it is essential to check the exact wording and to update or create the appropriate evidence.
In the near future you will also find a few working materials for your work:
The EU Madical Mevices Regulation does not include all relevant details but contains some authorizations for subordinated acts further specifying certain aspects.
To this end, the EU Commission can introduce two different types of documents that contain additional requirements:
What are the implementing acts?