Newsletter No 4 June 2019

Subject: MDR Preparation of the STS Medical Group, No.4 June 2019

Dear Customer,

At the beginning of our June edition of the monthly MDR Newsletter, we would like to thank you for the positive response received through various channels, such as our email address Maybe you would like us to pick up on a specific topic in one of our next newsletters? We are happy to receive your suggestions. In this fourth issue we would like to introduce you to the topic EUDAMED database in the context of the MDR.

What is EUDAMED?
EUDAMED is a comprehensive database system designed to increase the transparency with regards to medical devices for economic operators, notified bodies, public authorities, patients and users.

How is the EUDAMED structured?
The following diagram is showing the multitude of functions and information that EUDAMED will contain in the future.

What do these elements of EUDAMED mean in detail?
1. The SRN (Single Registration Number)
A manufacturer of medical devices must register themselves and of course their product in EUDAMED. Only then the product may be put on the market.
For this purpose, a registration must be made and various data of the manufacturer and the product must be transmitted. This data is reviewed and verified by the competent authorities. After verification and approval has been completed, the manufacturer receives a single registration number (SRN) from the database. This identifier refers to the manufacturer, and is the ID of the manufacturer in EUDAMED. It is foreseen that the SRN will be publicly available together with the manufacturer data, so that e.g. Patients or users will have access to this data. The identifier will have to be put on different documents in the future.
For example:
• On reports
• On the declaration of conformity
• For safety information or corrective actions on the market (FSCA/FSN)
• In connection with UDI
• Manufacturer’s certificates issued by Notified Bodies

2. UDI (Uniqe Device Identifier)
It can be assumed that the EUDAMED database will be the central authority for the UDI labelling required by MDR. For each product of a manufacturer, a corresponding UDI must be assigned here. Today, this happens e.g. through the GS1. Details on the regulation of the transition are still open at the moment.

3. Certificates
All certificates of a manufacturer, which are issued by a notified body, are stored in EUDAMED in the future. In addition, information about the status of the certificates can be viewed. If these have been:
• Withdrawn
• Reinstated
• Suspended
• Rejected
will be easily visible in the future.

4. PMS (Post Market Surveillance)
Various reports on trends on how products perform in the market (e.g. complaints) but also the so-called PSUR (Periodic Safety Update Reports) must be provided by the manufacturers here. These are then available to the authorities, Notified Bodies or the public.

5. Vigilance
In future, in the German market, for example, EUDAMED will replace DIMDI and serve as a database for the reporting of incidents. This includes all incidents as well as FSCA (corrective action on the market) and FSN (field safety notices)
At the same time, the UDI is the key for the assignment to the product in the database. For this purpose, a general form will be introduced for reporting purpose.

6. Clinical evaluation
The EUDAMED will store almost all clinical trial data. These also receive a unique ID under which the information is stored. For example:
• Manufacturer
• Description of the product under evaluation
• Sponsors
• Purpose and status of the evaluation

Status of implementation
Currently, there are still many questions left regarding EUDAMED. It is also unclear whether the full functionality of the database will be available on time. In the course of the MDR project STS Medical Group is preparing the IT framework based on the available information and is ready to align step by step with the progress of the EUDAMED.

This newsletter is part of our campaign to increase the sensitivity of all our business partners in relation to EUDAMED, to bring more clarity around the MDR journey and challenges and opportunities around the EUDAMED. We are already all dependent on a good cooperation and we will need even a closer collaboration in order to ensure safe supply to hospitals and patients in the future. Especially we are confident we’ll be able to continue to supply health care competently on customized surgical procedure sets and small kits.

You want to know more about specific topics?  Do you have any questions or comments?  Write us!

Augusto Orsini
CEO STS Medical Group

Uwe Goelz
Corporate Director Quality Management
and Regulatory Affairs