Regulatory Affairs Updates | CW13 21| qtec-group

Regulatory Affairs Updates 13/21

Medical Devices - Guidelines and Regulations Worldwide


Notified Bodies

It's getting tight: the date of application of Regulation (EU) 2017/745 is getting closer and closer and currently there are just 19 Notified Bodies available. For Regulation (EU) 2017/746, the situation is even more dramatic, as the participation of Notified Bodies under the Regulation will increase dramatically.

The European Commission has now updated their overview showing the number of Notified Bodies depending on their respective status in the certification process. Currently there are 23 (MDR) and 7 (IVDR) Notified Bodies in the certification process. You can see where exactly in the certification process the bodies are located in the document. It is available under the following link:

MDCG updates

The latest MDCG guidance answers the most frequently asked questions about custom-made devices. The focus is on the question of which products can be approved as custom-made devices and what requirements result from this for the manufacturers.


In a further guidance, the MDCG addresses the state of the art of Covid-19 rapid antibody tests. Both Directive 98/79/EC and Regulation (EU) 2017/746 are based on the generally accepted state of the art when assessing the intended performance of in vitro diagnostic devices. This makes it all the more important as a manufacturer to know this precisely. MDCG examined 102 instructions for use of Covid-19 rapid test. The results are summarized with regard to the modalities of performance evaluation and on diagnostic performance in this document.



The IMDRF has updated its terminology for categorizing adverse events. The total of seven annexes collect terms for the uniform naming of serious events and include terms for malfunctions of medical devices, patient and user outcomes, and parts or components of medical devices, as well as the associated codes for unique identification.

When reviewing the change log, it is noticeable: there are hardly any important changes. Many (assumed) changes result from so-called "editorial changes". Other changes to often very specific technical terms serve to improve comprehensibility. All updated lists and the change log can be found on the IMDRF page:

In addition, the IMDRF plans to publish a guidance primarily aimed at regulatory authorities. It will contain requirements to be used for the recognition and surveillance of Notified Bodies or Conformity Assessment Bodies (CABs).

The document is in draft status and proposals can still be submitted until mid-April. The Australian TGA has a succinct post on this on its website. The link to the IMDRF can also be found there.


Medical Device Reporting

In the U.S., manufacturers (unlike user facilities) are required to submit adverse event information to the FDA's Center for Devices and Radiological Health (CDRH). The electronic Medical Device Reporting (eMDR) project is available for this purpose.

The CDRH has promptly incorporated the changes in IMDRF terminology (see above under "worldwide") into their event codes. These lists are available on the FDA site as well as an overview of the changes:

Real World Evidence

The FDA's CDRH has also published a document that presents examples of real-world evidence (RWE).

The FDA uses RWE for "regulatory decision making": this allows novel products to be approved quickly and spares manufacturers the need to go through lengthy clinical trials. Also useful is a 2017 guidance that describes the process of obtaining RWE from real-world data (RWD). The current document includes examples from various regulatory processes such as de Novo, 510(k), and PMA.

Both documents can be found on FDA's page, which also includes commentary on RWD and RWE.


Getting approval or clearance in the US is not quite so easy to achieve. The information provided on a regular basis is all the more helpful for this. A brand new "resource center" has been set up on the subject of biocompatibility assessment. This is where information on evaluation by the FDA is bundled: What terms do you need to know, what are the documentation requirements, and what regulatory requirements must be met?

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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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