The EU Medical Device Regulation (EU) 2017/475

New Requirements

 You can read the full text of the

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.

What are the changes?

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.


Only days until the enforcement of the EU MDR.


E.R. was yesterday, today is GSPR

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:

  • General section (1-9)
  • Requirements for design and manufacture (10-23) 

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:

  • Template: "List of GSPR", download
  • Reference list E.R. bs. - GSPR, download

Delegated acts and implementing acts

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:

  • Implementing Acts
  • Delegated acts

What are the implementing acts?

  • An implementing act clarifies the "how" to implement. 
  • There are 31 authorizations for implementing acts in the MDR.
  • The basis is art. 291 of the TFEU and they need to pass through the "Appeal Committee".
  • Details of the implementing acts are given in Article 114 of the MDR.
  • The first Draft of an implementing act was published,  see News Blog.

Responsible Person

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