The roles and obligations according to the Medical Devices Regulation
Are you suddenly a manufacturer of medical devices?
It is still the case that operators in the medical technology industry must implement the new regulations from EU Regulation 2017/745 (Medical Devices Regulation, MDR for short) by the deadline of 26 May 2021. The reforms mean that, on the one hand, regulations have been tightened or newly created, as we have already outlined in other articles. On the other hand, “roles” are discussed for the first time in the EU MDR, the terms “manufacturer” and “distributor” have been redefined, and “economic operator” has been introduced as a superordinate term. As a result, the roles of some operators may change, as may their obligations.
But what are you now?
Manufacturer, authorised representative, importer, distributor?
This is a question you should investigate. As the MDR clearly defines the obligations associated with each of these roles, you need to know which role you have for which parts of your product portfolio.
Only a few companies will find that they are exclusively manufacturers of medical devices. For more frequently, you will find that you are a combination of manufacturer and distributor and even importer.
How to define your roles
To put it very simply, you take on the role of manufacturer of medical devices if you manufacture medical devices or if you reprocess them and market them under your own name or brand.
If you now buy in products that you do not market under your own name and which originate from an EU country, then you are a distributor. If these products come directly from a third country, then you are an importer. However, you can only import such medical devices for which the manufacturer from a third country has designated an authorised representative within the EU.
How can you suddenly become a manufacturer and what does this mean?
Using this definition, you can see how quickly you as a company can take on two or three roles in the medical devices industry. However, in principle it’s a question of operators like medical stores, who were just distributors until this point, suddenly becoming the manufacturer of a medical device by mistake, possibly unknowingly, and thus having to meet significantly higher requirements than as a distributor. This puts them in a more vulnerable position with regard to issues of liability. Article 16 of the MDR regulates “Cases in which obligations of manufacturers apply to importers, distributors or other persons” as follows: Distributors and importers must have a quality management system to ensure that the translation of information is correct and up-to-date, that the original condition of the product is maintained and that the packaging of the repackaged product is not defective, of poor quality or messy.
But don’t panic – regardless of the role or roles your company takes on in the future, there is a range of requirements that apply to all operators equally. In short, these have already been established in every company that is a distributor.
What can you do to not become a manufacturer?
To avoid having to meet the strict requirements on manufacturers, you should avoid making changes to the packaging units and changing the intended purpose. Both measures are of vital importance to medical stores in particular, as it is not uncommon for packaging units to change day-to-day. Even changes to the intended purpose – or departures from the purpose intended by the actual manufacturer – are made more quickly than expected.
The alteration of packaging is strictly regulated. This includes so-called relabelling, i.e. marketing a product under the name of your own company instead of that of the original manufacturer.
As a dealer, always stay strictly within the specifications given by the manufacturer. However, do not hesitate to contact the manufacturer if you require approval for special adjustments or if you need more leeway for specific products.
The mammoth task for manufacturers and how we can help
The factors mentioned above are putting even more pressure on companies in the medical devices industry, although complying with the EU MDR represents a challenge for manufacturers because of the new product labelling requirement alone. They not only need to ensure that their labelling system complies with the new regulations (product UDI serial number, name of a licensed EU representative for manufacturers outside of the EU, additional warnings and precautions for the product, a list of all the substances it contains, etc.), they also need to make sure that the users can receive information in a language they understand. The information supplied with the medical device must be supplied in the official language(s) of the European Union as determined by the Member States in which the product is made available to users or patients, and it must also be available in each of these languages on the company’s website.
Furthermore, the requirements to be fulfilled by the notified bodies in the audit procedure are to be calculated with considerable lead time and processing time, the complex requirements of this EU Regulation must be applied globally by all manufacturers and exporters that export products into the EU, and all companies must identify, understand and implement the new regulations within the specified time frames and under the supervision of the notified bodies, authorities and competitors.
Time is short and it is advisable to not wait until the last moment for the reasons mentioned above. If you need help with this important process, we’ll be delighted to assist you as an experienced language service provider.
to learn more about how we can help you.