Challenges of the MDR Article 16

Common practice of distributor/importers of medical devices is to perform changes in the packaging of medical devices. Many medical devices are available only in large packages so the need to separate the individual products according to the monthly requirements of the customer can be unavoidable. Health care insurers have a specific framework for reimbursement that can be based on specific packaging size and therefore large packages need to be repackaged to meet the requirements. There can be all sort of other reasons to perform repackaging of the medical device and/or change the size of the packaging.

Furthermore, distributors/importers may also have to translate the instructions for use for their customers and in order to meet regulatory requirements and be able to place the product on the market. This operation can vary from the simple addition of translated instruction previously prepared by the manufacturers to separate translation of instructions for use performed by the distributor/importer and then the addition of instruction to the final product.

From the regulatory point of view, these operations were unregulated as a “grey area” until May 2021 when directive 2017/745 becomes effective. According to MDR Article 16, a product-specific certificate is required for any and all repackaging operations performed on the medical devices by distributors/importers. Even in the case of non-sterile consumable goods and in cases when adequate packaging processes have been implemented, so there is no risk for the medical device, certification is still required.

Summary of Article 16 (2) distributor activities:

  • Provision and translation of (i) manufacturer’s label and instructions for use and (ii) any information necessary to market the device in the Member State (MS)
  • Repackaging necessary to market the device in the MS (condition of the device cannot be affected)

Article 16 of the MDR 2017/745 (EU) explicitly states that such activities, under certain circumstances, no longer constitute “prohibited” changes to the medical device so that a distributor or importer does not unexpectedly assume the responsibilities of the manufacturer any more. In particular, implementing an adequate quality management system is required for repackaging the product or translating instructions for use or labelling, and “[…] the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities […], attesting that the quality management system of the distributer or importer complies with the requirements laid down […].” [MDR Art. 16 (4)].

MDR Article 16

What does that exactly mean for distributors and importers of medical devices?

 

If activities such as translation or repackaging are unavoidable, the companies have to examine the requirements of Article 16 of the EU MDR, and then reviewed and adapted the QM system, or even developed an established QM system for the first time.

For performing these activities, you also require a product-specific “Article 16 (4) certificate” from a notified body, which has to be submitted to the responsible authority before starting the activity. For explanation purposes, the “Article 16 (4) certificate” is not equal to ISO 13485 certificate and they are not directly related nor supplementary.

Even if you already have ISO 13485 certificate as a distributor / importer of medical devices, you still require “Article 16 (4) certificate” for the described activities.

The certification process for “Article 16 (4) certificate” depends on the notified body performing the process. The basis for certification should be “Guidance for notified bodies on certification activities according to Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746” that is currently in draft. Compliance with the requirements has to be established and proven. A well-considered approach is necessary since these requirements are only defined at a very high level to date, and also to obtain the required certificate as soon as possible once the rules are defined.

Summary of Article 16 (3,4) distributor obligations:

  • Distributor to have a QMS in place to allow (i) Accurate and up-to-date translation of information, (ii) Preservation of the original condition of the device and quality of re-packaging, and (iii) Answering to safety issues and taking corrective actions
  • Distributor to indicate on the device (or packaging or accompanying document): (i) Activity carried out, (ii) Name, (iii) Registered trade name or trade mark, (iv) Registered place of business and (v) Contact address
  • 28 days prior to making the relabelled or repackaged device available on the market: distributors to (i) Inform manufacturer and competent authority (+ provide mock-ups) and (ii) Submit NB certificate attesting that the QMS is compliant

Whether you are a distributor or an importer seeking to relabel or repackage a device, or a manufacturer confronted with the necessity to have a distributor or importer relabel or repackage a device to meet local regulatory requirements, Medisint can assist you to identify the best strategy to suit your needs.