Communication between the different economic operators, notifying body and competent authorities is a prerequisite for any medical device industry. The coordination of all the aforementioned is essential for the successful designing, manufacturing, distribution, performance and quality maintenance of any product. Any event, change, incidence or complaint related to the performance of the product has to be communicated through a line of communication.
Under the MDD, it is the responsibility of Member States’ competent authorities and legal manufacturers to take safeguard and corrective measures against medical devices posing a risk to public health. However; Under the EU MDR, this responsibility has expanded to include importers and distributors. Thus, importers and distributors will be obligated to take all the necessary measures to prevent a medical device from being placed on the EU market, or even withdraw or recall it, should they have credible evidence that it does not comply with the requirements set forth in the EU MDR.
Should a device present unreasonable risk to the end users, importers and distributors should immediately notify the competent authority of the respective Member State and the Notified Body.
Additionally, importers and distributors should immediately forward to the manufacturer, or the authorized representative, complaints or reports from end users about suspected incidents with the relevant device.
For devices with higher risk profiles, manufacturers may need to carry out sample testing of marketed products, investigate complaints and keep a complaint log of nonconforming products and of product recalls and withdrawals. Manufacturers, authorized representatives and distributors must be kept informed of such events.
These new changes should be carefully taken into consideration when revising current supply and distribution agreements in compliance with the EU MDR and all parties of the agreement should enter into these new obligations with a full understanding of all responsibilities. Due to the importance of EU MDR requirements, obligations should be fulfilled with no delay in order to prevent any individual liability issues.
To understand the functioning of these lines of communication, three different instances, i.e. a) Complaint b) Incident and c) Recall
have been pictorially demonstrated below.
Fig. 1 Lines of Communication for Complaint
Fig. 2 Lines of communication for incident
Fig. 3 Lines of communication for Recall
Additional responsibilities introduced in the MDR for Importers and
Importers:
Where an importer considers, or has reason to believe, that a device is not in conformity with the requirements of the MDR regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer’s authorized representative.
Importers shall keep a register of complaints of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorized representative and distributors with any information requested of them in order to allow them to investigate complaints.
Importers shall co-operate with the manufacturer, the manufacturer’s authorized representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall is taken.
Where the importer considers, or has reason to believe, that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.
Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorized representative.
Where the device presents a serious risk, importers shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the Notified Body that issued a certificate in accordance with Article 56 for the device in question giving details in particular of the non-compliance and of any corrective action taken.
Additionally, the importer has a legally binding obligation to take its own corrective action when necessary and engage in post-market surveillance activities, which means that the agreement between the legal manufacturer and the importer will need to address how this will be effectively implemented.
Importers shall cooperate with competent authorities at the latter’s request on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market.
Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impractical, grant access to the device.
Distributor:
Where a distributor considers, or has reason to believe, that a device is not in conformity with the MDR requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorized representative and the importer. Where the distributor considers, or has reason to believe, that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
Distributors that consider, or have reason to believe, that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer’s authorized representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer’s authorized representative and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it as appropriate, is taken. Where the distributor considers, or has reason to believe, that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details of the noncompliance and of any corrective action taken.
Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available shall immediately forward this information to the manufacturer and, where applicable, the manufacturer’s authorized representative and the importer. They shall keep a register of complaints of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorized representative and the importer informed of such monitoring and provide them with any information upon their request.
Distributors shall, upon request by a competent authority, provide them with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
Distributors shall cooperate with competent authorities at their request on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or where that is impracticable, grant access to the device.
September 21st, 2021
