Changing the packaging of medical devices was and continues to be unavoidable, for instance for home care providers. Since they are not available in any other form, large packages of medical devices have to be separated to send products to patients according to monthly needs within the framework of monthly flat rate reimbursement by health insurers. Distributors may also have to translate the instructions for use for their customers.
From a regulatory perspective, these activities at best were unregulated as a ‘gray area’ to date. Even in case of non-sterile consumable goods and when adequate packaging processes have been implemented, so there is no increased risk, this is after all an encroachment on the medical device. Things are changing in May of 2021! A product-specific certificate is required.
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 labeling, 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)].
What does that mean specifically?
Such activities 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!
However, obtaining such a certificate is currently not possible. Because the EU Commission is significantly behind schedule with providing adequate guidance to the notified bodies. These are urgently needed!
For instance, the standard that will be used as the basis for a possible review/audit has not been defined yet. Presumably ISO 13485:2016 will play a role here, but to what extent remains unclear. Under what circumstances is repackaging or translation permitted? How product-specific do the issued certificates have to be? What does “...for the type of devices” mean? How are changes handled, for example, when a distributor adds a new or changed product to the portfolio? Is re-auditing at regular intervals required? In the meantime, an “Article 16” working group has been established by the EU Commission, and this working group has to address all these questions and need to set regulatory provisions.
“In view of the fact that one of the major aims of the EU MDR is to improve monitoring of the medical device supply chain, and consequentialy more frequent auditing of economic operators can be expected as well, it is difficult to comprehend that this topic has not been further developed by now. Distributors and importers are rightfully considered in EU law because they play an important role in making safe, effective medical devices available. However, the leeway which has been reasonable contemplated has to be made utilizable. Otherwise supply security in the market is at risk.”
For now, one can hope that the responsible competent authorities do not adopt a purely formal but a risk-based approach with a sense of proportion, and that notified bodies request clarification on this topic from the EU Commission.
What needs to be done prior to finalization of the EU MDR?
Distributors and importers confronted with this issue should perform a risk-based evaluation of their portfolio and applicable processes, and make any change needed. If activities such as translation or repackaging are unavoidable, the companies have thoroughly to examine the requirements of Article 16 of the EU MDR, and: the QM system has to be reviewed and adapted, or even developed and established for the first time.
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 rule are defined. After all, the innate focus of the EU MDR on the market and on providing medical devices will conceivably also lead to more auditing and monitoring of the distributors and importers. Proactive preparation is required.
gempex gempex is available for questions on the subject with professional expertise!
You have questions about this issue or want comprehensive support for the compliant provision of products to the market? The Medical Devices Team at gempex is specialized in the individual, risk-based evaluation of regulatory requirements, also for distributors and importers. The experts develop appropriate QM systems or derive measures tailored to the specific case in cooperation with customers. Perfectly fitting, with an eye on the specifics and compliance as well as efficient solutions.
Please contact Frank Studt, Managing Director gempex, via contact@gempex.com.