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Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

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26.07.2021

Caution, distributor! Or manufacturer after all ...?

As an economic operator in the field of medical devices, you can quickly mutate into a manufacturer with all the obligations due to relabelling and repackaging!

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... A loophole for previous PLMs!

As we have already presented in the article "Riding the wave means being successful!" obligations for economic actors have been formulated in the MDR.

But beware, if certain activities are carried out around and on the product, you may make yourself a manufacturer! A look at Article 16 of the MDR.

When does this scenario apply? Well, these include, among others:

  • Changes in the intended purpose of a medical device already placed on the market;
  • Modifications to a medical device already placed on the market or put into service which no longer guarantee compliance with the essential safety and performance requirements;
  • Changes to the information next to the manufacturer's symbol.

If you make changes to the product, to the labelling or to the intended use, the manufacturer's obligations of the MDR will thereby also apply to you in most cases!

Therefore, you should make sure that you have an agreement with the manufacturer if you want to make the product available on the market under your brand. This must stipulate that the manufacturer is responsible for compliance with the relevant MDR requirements and that you only act as a distributor.

It must be clearly visible on the product who the manufacturer is! The corresponding standardised symbol must be used.

But which changes have no influence on the manufacturer's obligations? In other words, what are you allowed to do as a distributor without becoming a manufacturer according to the MDR?

  1. You may carry out activities of assembly or adjustments to a patient.
  2. You may provide product information or translate existing information. This is particularly interesting and important for distributors of products that are not yet available in the national language of the target country.
  3. You may make changes to the outer packaging or pack size if this is necessary for marketing in a specific European country (e.g. within the framework of reimbursement). Please note that the original condition of the product must not be affected, especially in the case of sterile products! The sterile barrier must not be opened during repackaging, otherwise further manufacturing steps - packaging and sterilisation - would have to be carried out here. And these would then in turn make the distributor/acting party the manufacturer.

Points b) and c) in particular are likely to be the most interesting for distributors as well as previous "Private Label Manufacturers" (PLM) who have piggybacked on the conformity assessment procedure of the Original Equipment Manufacturer ("OEM") according to MDD. The MDR is a little more specific here:

Economic operators such as distributors or importers who provide translations or repackage:

  • indicate on the packaging or, where appropriate, in a document accompanying the product, the activities carried out, the name, registered trade name or trade mark, the registered place of business and the address at which he can be contacted.
  • have a quality management system (QM system) to ensure the correctness of the activities carried out.
  • For translations, the QM system must include a procedure to ensure that the translation of the information is correct and up to date. The product must not be incorrectly labelled or packaged, and the quality should be consistent.

In the case of repackaging, the QM system shall include a procedure to ensure that repackaging activities are carried out by means and under conditions that ensure that the original condition of the product is maintained and that demonstrate that the repackaging of the repackaged product is not defective, untidy and of poor quality.

It is important that the QM system also includes procedures to ensure that information from the manufacturer on all corrective actions is also taken into account by the distributor or importer.

Economic operators, such as distributors or importers, who repackage or relabel products shall take into account the following at least 28 days before making those modified products available on the market:

  • They must inform the manufacturer and the competent authority of the Member State that they intend to make the repackaged/ relabelled product available on the market.
  • You must provide the manufacturer and the competent authority with a sample or model of the repackaged or relabelled product on request (including the translated labelling and instructions for use).

The distributor or importer must then submit a certificate from the notified body to the competent authority within the same 28-day period. This certificate shall relate to the named product and shall certify that the repackaging and/or relabelling operation is included in the distributor's or importer's QM system and complies with the regulatory requirements.

For importers and distributors, this is certainly a big challenge and means a lot of new processes. For existing PLMs, however, Article 16 could be attractive to continue selling products under their brand - but, mind you, not placing them on the market.

As explained above, a good contractual and general relationship as well as functioning communication between the economic operator and the manufacturer are important in each of the cases shown in order to fulfil the requirements and wishes on both the customer and the legal side.

Have we aroused your interest as a distributor or importer to take on this task? As a previous PLM, did you not yet have a solution for the OEM products under your umbrella brand? We would be happy to help you close the regulatory gaps for Article 16 of the MDR.

 

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.

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