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Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

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30.10.2020

Knowing who you are. Knowing what you have to do.

Importer, distributor or manufacturer? Or all at the same time. MDR gives exact descriptions of the roles and their consequences. The experts at seleon have evaluated and noted this in detail. There is no better way to prepare for goods traffic from abroad.

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Who am I? Am I still an importer, a distributor or even the manufacturer? Many medical device companies and their partners are asking themselves these questions, as the soon to be valid MDR reshuffles the roles and obligations of economic actors within the medical device industry or defines them for the first time. This also includes the role of the importer. The importer is subject to his own set of obligations and the associated liability risks. Importers must even assume the obligations of the manufacturer in special cases.

 

Who is an importer according to MDR?

"Importer" means any natural or legal person established in the Union who places a product from a third country on the Union market.

 

What do I have to do? General obligations of importers are regulated in Article 13 of the MDR.This article sets out not only the obligations relating to product conformity but also the relations between importers and other economic operators. In addition to Article 13, all requirements directed at economic operators apply.

 

Review, report and cooperate

The interaction between importer, competent authorities and other stakeholders can be structured as follows:

 

  • The importer must check that the manufacturer has complied with his obligations. The following information must be available:
    • The validity and accuracy of the CE marking and the EU declaration of conformity for the product (Article 13(2))
    • The indication of the manufacturer on the product (Article 13(2))
    • The indication of the authorised representative according to Article 11 of the MDR on the product (Article 13(2))
    • The labelling of the product and the instructions for use in accordance with MDR (Article 13(2))
    • The UDI according to Article 27 of the MDR (Article 13(2))
    • The registration of the product in the electronic system according to Article 29 of the MDR (currently via DIMDI/BfArM) and the completion of the registration with own data according to Article 31 of the MDR (Article 13 para. 4)
  • The importer must notify and/or inform about
  • If the product does not comply with the requirements of the MDR, the importer may not place the product on the market until conformity of the product has been established. The manufacturer and the authorised representative must be informed (Article 13(2)).
  • In case of high risk or falsified products, the competent authority of the Member State must be informed (Article 13(2)).
  • keeping a register of complaints, non-conforming devices and recalls and withdrawals and making it available to the manufacturer/authorised representative (Article 13(6))
  • In case of non-conformity of a product placed on the market by the importer, the manufacturer and, where appropriate, his authorised representative must be informed immediately (Article 13(7)).
  • In the event of a serious risk, the competent authorities of the Member States in which the importer makes the product available and, where appropriate, the competent notified body must be informed immediately (Article 13(7)).
  • Immediate notification of the manufacturer and the authorised representative of suspected incidents relating to the device (Article 13(8))
  • For at least 10 years after the last product has been placed on the market (15 years for implantable products), identification of all economic operators/healthcare institutions/healthcare professionals to whom the product was directly supplied and all economic operators from whom the product was directly purchased, to the competent authority (Article 25(2))
  • The importer must cooperate to the extent indicated below:
    • With the manufacturer, the authorised representative, with the competent authorities in all preventive or corrective actions, recalls and withdrawals (Article 13(7))
    • With the competent authorities in any action taken to prevent or reduce risks (Article 13(10)); making available free of charge product samples or the information accompanying the product at the request of the competent authority; if this is not readily available, he must grant access to the device (Article 13(10))
    • With distributors, to be informed of any non-conformity of the device and of any preventive or corrective action, recalls and withdrawals by the distributor (Article 14(4)); to be informed of suspected incidents relating to the device  (Article 14(5)) and to be informed of the register kept by other distributors concerning complaints, non-conforming devices and recalls and withdrawals (Article 14(5))
    • With distributors and manufacturers to ensure the traceability of the device (Article 25(1))
    • With the competent authority, where the authority has identified an unacceptable risk or non-conformity resulting from market surveillance activities (Article 94), the importer shall ensure that all appropriate corrective actions are taken in relation to devices made available on the market (Article 95(3))

 

Marking, transport, storage and documentation

  • information provided by the importer on the labelling of the device, on its packaging or in the accompanying documents (name, registered trade name or registered trade mark, registered place of business and address) without obscuring information provided by the manufacturer (Article 13(3))
  • compliance with storage and transport conditions as specified by the manufacturer while a device is under the responsibility of the importer (Article 13(5))
  • Retention of the documentation for at least ten years after the last placing of the product on the market, for implantable products at least fifteen years, (EU declaration of conformity, certificate, amendments and supplements) (Article 13(9))

Electronic system for the registration of economic operators, currently via DIMDI/BfArM in Germany, later Europe-wide Eudamed (certain data is publicly accessible):

  • The importer registers in the electronic system referred to in Annex VI, Part A, Section 1 (Articles 30(1), 31(1)).
  • Where a Notified Body is involved in the conformity assessment procedure, registration must take place before the application is submitted to the Notified Body (Article 31(1)).
  • After the inspection, the importer receives a single registration number ("SRN" - Single Registration Number) from the competent authority (Article 31 (2)).

Attention! The module for obtaining the SRN will go live on 1 December 2020! 

  • Within two weeks of placing the device on the market, the importer shall verify the registration of the manufacturer/authorised representative in the electronic system and the information entered (Article 30(3)).
  • If the data entered in the system changes, the importer must update the data within one week (Article 31(4)).
  • When an economic operator changes, the competent authority must be informed and the data in the electronic system updated accordingly. Economic operators should clarify among themselves who is to be notified in order to ensure identification within the supply chain (Article 25).
  • Not later than one year after the first submission and every two years thereafter, the importer shall confirm the accuracy of the data (Article 31(5)).

 

Liability

  • The importer is liable for defective devices if the manufacturer established outside the Union has not complied with his general obligations (recital 35).
  • The importer is jointly and severally liable with the authorised representative and the manufacturer (recital 35).

 

When do the manufacturer's obligations under Article 16 of the MDR apply to the importer?

  • When carrying out any of the following activities, the importer assumes the obligations of the manufacturer (para.1)
    • Making a product available on the market under its own name, for example where the own trade mark is used or where the manufacturer is not explicitly identified (exception: an agreement with the manufacturer whereby the manufacturer is identified as such on the label and is responsible for compliance with the MDR requirements applicable to manufacturers);
    • Change of intended purpose of a device already placed on the market;
    • Modification of a device already placed on the market in a way that could affect its conformity (exceptions: provision including translation of the accompanying documentation, modification of the packaging/repackaging without damaging the original condition)

If one of these activities is carried out by the importer, the importer assumes further obligations:

    • In the event of a change of information or packaging, the importer shall indicate on the device, on the packaging and/or on the accompanying documents his name, registered trade name or registered trade mark, registered place of business and address (paragraph 3).
    • The importer must have a QMS for the procedures relating to the activities carried out, including procedures to ensure that he is informed of any corrective action taken by the manufacturer (paragraph 3).
    • At least 28 days before the relabelled or repackaged product is placed on the market, the importer must inform the manufacturer and the competent authority of his intention (para. 4).
    • Where appropriate, he must provide the manufacturer and the competent authority on request with a sample or model, including the translated marking and the translated instructions for use (paragraph 4).

 

What am I not responsible for as an importer?

  • The importer is not responsible for ensuring the correctness of the product conformity assessment procedure, i.e. the verification of documents and markings is mainly the responsibility of the manufacturer and his authorised representative (Article 11, 3a).
  • If a competentauthority in the Member State where the authorised representative has his registered place of business requests a sample of or access to a product, the importer does not have to forward this request to the manufacturer and does not have to verify that the competent authority receives the samples or access to the product (Articles 11, 3e).
  • The importer is not liable for defective devices on the same basis as the manufacturer (Articles 11, 5).
  • The importer is not responsible for terminating the mandate if the manufacturer breaches his obligations under the MDR (Article 11, 3h) and for informing the competent authority without delay (Article 11, 6).
  • He is not responsible for applying for a certificate of free salen for export purposes (Article 60, 1)
  • The importer does not need permanent access to a qualified person  responsible for ensuring compliance with the regulatory requirements (Articles 15, 6)

 

All these described responsibilities lie with the authorised representative. Even if the listed obligations are not the responsibility of the importer, the importer must ensure that there is an authorised representative to fulfil these obligations.

 

Are you still seeking your role in the MDR? Have you perhaps acted as a distributor up to now, but perhaps you see yourself more as an importer? Have you been approached by a non-European company about import possibilities? But you did not have any regulatory requirements in your catalogue of offers so far? We are happy to offer you the necessary regulatory support for an MDR compliant QMS for you as an importer. Simply contact us without obligation.

 

 

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

CONTACT YOUR SELEON SPECIALIST

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