Newsletter No 28 November 2022

Subject: Distributor role as MDR economic operator

Background

The Medical Devices Regulation 745/2017 (MDR), with the aim at enhancing medical device safety, has developed economic operator requirements including new roles and responsibilities.

Economic operators are:

• manufacturers,
• authorized representatives (if production is performed outside EU),
• importers (if production is performed outside EU)
• and distributors.

As stakeholders in placing medical devices on the market and distributing within the EU territory, they are required:

1. to share information on the safety and performance of the products,
2. to manage EUDAMED registrations (excepting for the distributors)
3. and in the future to provide notifications to notified bodies and national competent authorities (NCAs).
4. They also need to manage labelling translations, NCA registrations, and verification of regulatory documents provided by the other interested parties as applies to each role.

In case of manufacturers established in the European Union, the economic operators involved are only manufacturers and distributors.

How are the responsibilities agreed between manufacturer and distributor?

The responsibilities of each party are set in quality agreements to ensure that the obligations of MDR and any other laws applicable in the territories where the products will be marketed are met.

Therefore it goes without saying that having established contracts between manufacturer and distribution is not an option any longer but has become a mandatory requirement for clear application of the regulations.

What are the main topics covered in the quality agreement?

The quality agreement typically includes the following:

• Identification and contacts from manufacturer and distributor
• Terms and definitions
• Scope: product families or product references, activities, territories where the products will be marketed, applicable legislation and contract duration
• Responsibilities of the manufacturer: maintain valid MDD/MDR CE marking, establish UDI labelling, register the actor and products in EUDAMED, notify changes to the distributor, manage manufacture, storage and distribution, traceability, handle complaints, vigilance reporting, manage post-market surveillance (PMS), corrective actions and field safety corrective actions, provide labelling in the languages required according to the territories where the products will be marketed. The person/s responsible for regulatory compliance (PRRC) is required.
• Responsibilities of the distributor: handling, storage and distribution, product traceability, timely notification of complaints, participation in corrective actions and in field safety corrective actions, act as an interlocutor for NCA requests.

To be noted: as a distributor you are expected to…

1. Have a Quality Management system in place to ensure compliance to the described responsibilities. There is no mandatory requirement of establishing ISO 13485 certification although implementing this certification makes simpler aligning the distributor QMS to the regulatory requirements.
2. Verify that the products have been CE marked and that the EU declaration of conformity of the device has been drawn up, that the device is accompanied by all the information to be supplied by the manufacturer, that the languages required in the country are included on the label and where applicable that a UDI has been assigned by the manufacturer.

The NCAs may conduct inspection at the distributor facilities to verify your compliance to MDR distributor role.

Further information is available at Article 14 and 16 of the MDR, and in guidance documents MDCG 2021-27 and MDCG 2021-26.

Do non-EU distributors require quality agreement?

All distributors require quality agreement with the manufacturer in order to set the regulatory responsibilities required in the territories where the products will be marketed such as management of facility and product registrations, traceability, UDI, translations into official languages, incident and field safety corrective actions. They are also required, and to share information regarding complaint notification, vigilance, field safety corrective action management, notification for suspected counterfeit, and post-market surveillance that are required according to the MDR.

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 efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supply to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.

The next MDR newsletter will be issued in December. We wish everyone productive and pleasant days.