Newsletter No 2 April 2019

Subject: MDR Readiness at STS Medical Group

Dear Customer,
This is the second release of STS MDR monthly newsletter after the very positive feedback received with the March kick off of this initiative. In this April hand-out the selected subject is the newly introduced concept of the economic operators which extend the responsibilities for the quality of the medical devices brought to market to all the legal entities acting across the supply chain.

What is the background of this change?
One major goal of the revision of the Medical Device legislation was to improve the traceability of all devices present in the European market while providing both users and patients more possibilities to check if a product is CE marked accordingly to the existing regulations.

For this purpose two new tools were introduced:

• a new codification (unique device identifier) defined as UDI;
• and a European database for all the medical devices (EUDAMED).

Aiming to enforce the applications of these requirements, the responsibilities were extended from the manufacturer to all the other companies acting across the supply chain (gathered under the term “economic operators”).

The idea is that distributors and importers shall cooperate with manufacturers or authorized representatives to achieve an appropriate level of traceability of all devices and to implement additional layers of control to ensure that a device is compliant to the Regulation when placed on the market.

Who is an economic operator?
The MDR clearly spells out responsibilities of legal entities involved in the supply chain of medical devices and thus extend the scope of the legislation beyond the requirements on the sole manufacturer. These are in all cases

• the distributors

And where the manufacturer is outside the EU

• the authorized representative and
• the importer

What are the new requirements for Importers and Distributors?
Especially for importers and distributors new responsibilities have been set up for checking the correct registration and labeling of each device.
For products where the legal manufacturer is outside the EU, under the MDD only the name and address of the authorized representative (named as AR) needs to be identified on the label. With the introduction of MDR new information have become mandatory on the label (or in a document accompanying the device) as:

• the importers registered name;
• the place of business;
• the address at which they can be contacted.

Authorized representative, importer and distributor
need to verify that the product is

• CE marked;
• has a valid declaration of conformity;
• and the legal manufacturer holds relevant
  certificates.

The importer needs to be registered in the EUDAMED database and has the obligation to verify that the necessary information for the device has been entered into the database.
Both, importer and distributor need to makes sure that the label and all information associated with the product are in the correct language and are compliant with the requirements of the MDR.
Importers and distributors have the responsibility to inform the other economic operators in the event of complaints. They should keep a register of complaints, non-conforming devices, recalls and withdrawals, and escalate non-compliances to authorities if they suspect that a device has been falsified or about safety when there is a serious risk to health.

If a distributor considers a device to be non- compliant with the Regulations, the device shall not be made available on the market.

What is STS doing to achieve compliance?
Companies of the STS Medical Group take different role within this definition of the economic operator when looking at the product portfolio we bring to the market. We are the manufacturer of most of the products we have in our product range.
We act as a distributor for all the components we offer in our procedure packs and may sometimes become the importer of components that we source from manufacturers outside the EU to include them in the procedure packs.

In preparation of the implementation of the new requirements, a few steps become mandatory to ensure compliance as:

• the mapping of our specific role in the Nsupply chain for each product;
• the revision of the labelling requirements;
• the upgrade of the contracts we have with our business partners to make sure that the specific requirements related to our role in the supply chain are covered.

We also are required to review our existing procedures for incoming inspections and complaint management.
As a manufacturer, we will receive many requests from companies that act as our distributors – including other providers of procedure packs – that need to collect specific information from us to be able to fulfill the same requirements. We are preparing to have the relevant information always available to support our distribution partners according to the law and their expectations.

At the same time, we also need to approach the manufacturers of the components we distribute within our procedure packs. We have to up-date the existing files in our component database to be able to fulfill all our obligations as distributors and in a few cases as importers. This newsletter is actually part of our campaign to raise the awareness of all our business partners. We all need to cooperate to enable all of us to continue supplying hospitals and patients with the required customized solutions for surgical procedures.

Would you like to learn more about specific topics? Do you have comments or questions? Do you wish to provide us a feedback?