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Regulatory Affairs Updates 20/22

Medical Devices - Guidelines and Regulations Worldwide


Update of Harmonized Standards under MDR and IVDR

The mills of the European Commission grind slowly, but now new standards have been harmonized under the regulations for medical devices and in vitro diagnostics.

Oh well, it was perhaps foreseeable that EN ISO 13485:2016 and EN ISO 14971:2019 would be harmonized under Regulation (EU) 2017/746. Regulation (EU) 2017/745 is donated EN 285:2015+A1:2021 (sterilization) in addition to the two.

The two documents with all the information have been published on the website of the Commission:

Guidance on transitional provisions of the IVDR

For manufacturers of medical devices under the MDR, this topic is already old hat. Now, however, there is also guidance for the IVDR on Article 110(3) and the so-called significant changes. The new document is explicitly based on the MDCG 2020-3 document, and the principle also remains the same: no change to the design or intended purpose - no problem.

Otherwise, it gets a bit more complicated. The various decision trees and the practical examples will help with the exact assessment. It remains to be hoped that manufacturers of in vitro diagnostics either do not want to make any more significant changes or already have a regulatory strategy for the coming years. After all, the deadline is already May 26, 2022.

As always, the document can be found on the MDCG page:

Guidance on borderline products

This new MDCG Guidance 2022-5 on combination products and medical devices has caused quite a stir.

Compared to many other Guidances, this one is particularly detailed and takes a lot of time and space to compile clear definitions from the various applicable regulatory frameworks.

Products containing herbal (active) ingredients are now classified higher or do not fall under the scope of the MDR at all. In addition, the likelihood that a product will now have to go through a consultation process has increased significantly. The complete document can be found under the following link:

International News


Final Document on Post-Market Surveillance

The IMDRF has once again published a very exciting document. It deals with the reporting of incidents and it would be desirable if these proposals were adapted by as many regulatory authorities as possible in order to ensure a uniform regulation worldwide.

Especially the existing discrepancies in the definition of incidents and the different deadlines cause problems again and again and are difficult to map in global processes without losing the overview.

In addition, the document also describes the collaboration between national authorities to ensure the efficient dissemination of information on public health threats.

The document can be downloaded from the IMDRF website:


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All updates compiled in one PDF file:

You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.

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