Newsletter No 19 November 2020

Subject: Economic Operators and Registrations
Introduction:
In May 2021, Europe’s medical device regulation (EU MDR) will go into effect, replacing the existing medical device directive (MDD) that is currently in place.
The EU MDR requires total lifecycle traceability between all stages of medical device development and post-market activities. Demonstrating traceability throughout the product lifecycle, known as closed-loop traceability, is a revolutionary approach to quality management that many industry professionals never thought possible.
To keep track of devices through every lifecycle stage, a device identifier will be assigned and all production series will be marked with a production identifier. These tracking measures satisfy the new mandate for Unique Device Identification (UDI), which is entered into the EUDAMED database.

UDI information must:

• Be placed on the medical device’s package or label.
• Follow globally used formats.
• Include the EC representatives’ detailed information, including name, address, and symbol.
• Be published electronically to the manufacturer’s website (if applicable) and also be available in print.

Under EU MDR, economic operators now include manufacturers, authorized representatives, importers, and distributors. These entities will be expected to take on an increased level of responsibilities throughout the medical device supply chain process

To ensure traceability and safety for devices being marketed in Europe, EU MDR imposes an entirely new set of requirements for importers and distributors (see the previus 2 newsletters).
In addition, new requirements for economic operators include verification of compliance, cooperation in complaint handling and field safety corrective actions, and, of course, cooperating with manufacturers and Competent Authorities in device traceability. The purpose of EUDAMED is to create an accessible repository of device-related information for patients, regulators, notified bodies, and manufacturers to access data for medical devices being marketed in the EU and help improve overall post-market surveillance.

Let´s have a closer look at registrations deadlines ...

1. Legacy devices – covered by a valid Directive certificate – that will continue to be placed on the market after the MDR date of application should be registered in Eudamed without a Basic UDI-DI and UDI-DI. The registration deadlines for those devices is clearly the one referred to in Article 123(3)(e): 18 months after the date of application (provided that Eudamed is fully functional on time).

2. However, in case of serious incident or field safety corrective action to be reported during the 18 months referred to in point 1, where the legacy devices have not been registered in Eudamed yet, they must be registered at the moment of the serious incident/field safety corrective action reporting.

3. Point 1 will be applicable only to the devices that are not already registered as MDR devices.

NOTE: All the Directive-compliant devices which have been placed on the market ahead of the general application dates and will not continue to be placed on the market afterwards, should be registered in Eudamed (without a Basic UDI-DI and UDI-DI) only if a serious incident report and/or a field safety corrective action report (with the field safety notice) occurs after the application date.

Let´s have a closer look at registrations obligations …

The European Medical Device Coordinating Group (MDCG) has set a deployment date for an important component of the Eudamed database for registration of economic operators. According to a recent position paper, MDCG plans a December 1, 2020 deadline for rolling out the “actor registration module” of Eudamed.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.
We are already today all dependent on an effective cooperation. For the MDR implementation, we require even a closer collaboration in order to ensure we all can deliver safe supply to hospitals and patients in the future.
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 MDR2020@stsmedicalgroup.com
The next MDR Newsletter will be issued in December. We wish everybody pleasant days.