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Transparency arrangements under MDR

One of the main ideas behind the development of the MDR is the goal to improve transparency of the whole CE marking system. Several requirements have been introduced to make information more easily available to the general public and also, to a higher level, to facilitate a transparent communication between the various players, such as Notified Bodies, economic operators, national competent authorities and Commission.

Since those requirements, although clearly included in the text of the regulation, are quite widely spread across 123 articles and 17 annexes the Commission has recently published a factsheet to summarize the information that will become available to the general public  once the Regulation is fully implemented, including full EUDAMED functionality.

The document divides the public data into two groups, the information that will be made available through EUDAMED and the information that will be provided through other channels.

Once EUDAMED is fully rolled out, so hopefully by May 2022, the following information will be available for everyone to consult:

  • Registration of all manufacturers, authorised representatives and importers
  • Registration of devices, including the core elements of the UDI database (Annex VI, Part B)
  • Certificates, including scope and validity
  • List of Notified Bodies
  • Scientific opinions of the expert panels and written justification of the Notified Body in case the opinion was not followed
  • Clinical investigation reports and their summary
  • SSCP
  • Incident reports and field safety notices
  • Summary of the results of market surveillance activities on their national territory by each EU Member State.

Some more information will be publicly available, although through means other than EUDAMED. For the first time the focus will not be only on manufacturers and Notified Bodies but also on competent authorities. The way they operate, they fund their activities and oversee the work of Notified Bodies will be to some extent subject to public scrutiny with the following information being made public:

  • National measures taken by competent authorities for the placing on the market of single use devices which are reprocessed,
  • Types and levels of fees levied by Member States for funding activities carried out by the competent authorities,
  • National measures governing the assessment, designation and notification of Notified Bodies,
  • Summary of each Member State report on its monitoring and on-site assessment activities regarding Notified Bodies,
  • Commission annual summary report of the peer review activities of authorities responsible for Notified Bodies.

Not surprisingly also Notified Bodies will have to operate in a more transparent way and publish the declaration of interests of their top-level management and the list of standard fees applied. Some Notified Bodies are already adhering to this last requirement and are publishing their price list however so far the results are quite underwhelming in terms of transparency: declaring the hourly rate charged for a service possibly meets the requirement but certainly doesn’t allow to understand and compare a price structure. We know that different Notified Bodies have very different price structures and the number of hours charged for the same service can vary significantly so the publication of the hourly rate seems to be a fig leaf that doesn’t add much to the actual transparency of the system.

So quite a lot of information will be out there, especially for high risk devices, for everyone to scrutinize. This enforced openness will certainly have an influence on the behavior of all the main players, from competent authorities to Notified Bodies to manufacturers and all the way down the supply chain. And hopefully the effect will be positive and not resulting in the system coming to a standstill because of fear of being publicly shamed.

For support, check out our regulatoryquality and clinical services.

Date d'envoi: juillet 23, 2020
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