A fresh perspective
The EU Commission’s new Medical Device Regulation (MDR), published in May 2017 and applicable from the 26th May 2020, significantly changes the importance of economic operators in the healthcare industry and their responsibility in protecting patient safety. Whilst the previous Medical Device Directive (MDD) does not mention the word “distributor” at all, the EU’s new MDR has redefined distributors in a new light.
Distributors have been identified as a key point of contact in the industry that can ensure the safety and market transparency of medical devices on the EU market, and are defined by the MDR as “any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service.”[1]
The new role and responsibilities
Before making a device available on the market, distributors are responsible for verifying that a device is compliant with the obligations described in Article 14 of the MDR/IVDR and that the following regulatory requirements are met, including that:
- a device has been CE marked and that an EU Declaration of Conformity has been drawn up;
- labels and instructions for use are provided in the official languages of the Member States (or in languages accepted by those Member States);
- the device is accompanied by the information required by the MDR and supplied by the manufacturer;
- the importer’s name is indicated on each device or in the accompanying documentation and that the device bears, where applicable, a Unique Device Identification (UDI), assigned by the manufacturer;
- for imported devices, the importer has complied with the requirements set out in Article 13(3) of the MDR;
- when a device is under their responsibility, the storage and transport conditions are appropriate and in line with the recommendations of the manufacturer;
- if a distributor considers a device to be non-compliant with the MDR, the device should not be made available on the market and the distributor should inform the other economic operators;
- distributors should also inform the authorities if they suspect that a device has been falsified or that there is a serious risk to health;
- distributors should keep a register of complaints, non-conforming devices, recalls and withdrawals and that they should cooperate with authorities and make available all the documentation and information they have at their disposal.[2]
Reporting to competent authorities (CA)
A distributor is now responsible for reporting to competent authorities (CA) if a device poses a risk to patients or does not meet the standards set out in the MDR. In readiness for an audit or on request by the CA, they must also be able to provide the CA with all the information and documentation at their disposal and necessary to demonstrate the conformity of a device. Finally, distributors will now work with CAs on any action taken to eliminate the risks posed by devices that they have made available on the market. This includes providing free samples of a device or, where that is impracticable, granting access to a device.
Preparing for the challenge
Whilst distributors do not need to be designated or certified by the MDR, it will be far easier for them to follow the MDR requirements if they have a Quality Management System (QMS) based on its ISO 13485. This will ensure that their system will only distribute MDR compliant products, can detect defective products and maintains the traceability of products even in the event of a label change.
Fully training your team will also make sure that the distributor role runs efficiently and effectively. This includes training in:
- the requirements of the MDR and the distributor’s regulatory responsibilities;
- dealing with CA;
- storing, preferably electronically, the UDI information for Class III devices;
- the service agreement between themselves and manufacturer.
Wider obligations for distributors
There are a number of instances when the tightly regulated obligations for manufacturers apply to distributors. This can happen if a distributor:
- makes a device available on the market under their name, registers a trade name or registers a trade mark (except when a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label);
- changes the intended purpose of a device already placed on the market;
- modifies a device already on the market in a way that affects its compliance with the regulatory requirements.
In these instances, a distributor would be obliged to have a QMS that meets the requirements of the MDR, including:
- procedures that ensure information is up-to-date and translated with accuracy;
- that the original condition of the device and its new packaging is not defective, of poor quality or untidy;
- ensuring that they are informed of any corrective action taken by the manufacturer in relation to a device so that the distributor can respond to safety issues or to bring it into conformity with the MDR.[3]
From events to training programmes, consultations to quality management strategies, The Tao of Excellence has specialist expertise and experience that can assist distributors in their new roles and optimise their success in the industry. Please contact us at [email protected] or visit our website for more details on our services and to learn how we can assist you with the new MDR.
Deepa Rajagopalan
Phone
+41 52 685 51 65
Email
[email protected]
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[1] Official Journal of the European Union, MDR, Regulation (EU) 2017/745, Article 2, 5 April 2017: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
[2] EU Commission, Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices, 5 February 2019: https://ec.europa.eu/docsroom/documents/33862
[3] Official Journal of the European Union, MDR, Regulation (EU) 2017/745, Article 14 & Article 16, 5 April 2017: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
