Regulatory reform of medical devices
New EU Regulations on medical devices (MD) and in vitro diagnostic medical devices (IVD) have replaced the directives of the 1990s. The new Regulations had a transitional period, which ended in May 2021 for the MDR and May 2022 for the IVDR. Regulations are legislation directly applied in all EU countries, unlike directives, which require changes to the national laws.
Improved patient safety
The main objective of the regulatory reform was to improve patient safety. Previously in the EU, manufacturers were themselves able to label the majority of their IVDs with a CE mark. In the new Regulation, changes were made to the principles of IVD product risk classification and, as a result, a large part of the devices must now be assessed by a third party (a notified body). Now, the regulation of medical devices in EU has been brought to an internationally comparable level.
The old Directive focused mainly on the responsibilities of MD manufacturers. The new Regulation describes the products’ entire distribution chain: manufacturer, importer, distributor and user. Each operator has their own defined responsibilities.
Operators of the MDR and IVDR
The Manufacturer still has the main responsibility for the product. The reform means that, in addition to their other responsibilities, manufacturers must more actively monitor the use of the product and gather information about the functioning of the product.
The Importer is an operator that first places a product from a third country on the Union market. Importers are responsible for ensuring, for example, that products on the market comply with requirements and their packaging bears the necessary CE markings. In addition to the manufacturer, packaging must contain the contact details of the importer.
The Distributor is defined in the Regulations as an operator in the distribution chain, other than the manufacturer, importer or user. A distributor is a link that purchases a product from a manufacturer or importer and distributes it to the user. Distributors must be able to track the products they sell to ensure that their movement can be tracked all the way from the manufacturer to the user, when necessary.
A Notified body is a company who, at the request of the manufacturer, assesses both the manufacturer’s quality system and the MD itself for the purpose of CE marking. Notified body status must be applied for from the competent national authority (in Finland, the Finnish Medicines Agency Fimea).
Triolab is an importer and distributor
Triolab is an importer for some of the products it sells, and a distributor for others. The majority of products represented by Triolab are IVDs, and a small portion falls under the scope of the MDR. Triolab’s product portfolio also includes research products and veterinary products, which are not covered by the new Regulations.
Traceability and processing of customer feedback in cooperation with the product’s manufacturer are an essential part of the distribution chain, and already at a high level at Triolab. With the new Regulations, Triolab’s product information system includes more detailed information on the manufacturer, importers, as well as the products’ regulatory status and risk class. At Triolab, Quality Manager Eriikka Heikkinen is responsible for regulation issues.
Implementing the changes brought by the requirements of the IVDR and MDR has been a challenging and interesting project. At the same time, I have gained a deeper insight into the company’s processes related to product lifecycle management and product information. – Eriikka Heikkinen
Help from the trade association
In addition to the actual Regulations, EU produces plenty of instructions on the IVDR and MDR. The regulation expert of Sailab – MedTech Finland, a trade association for the health technology industry, constantly monitors the news feed and informs the member companies of key issues that affect Finnish companies.
The guidance from the authorities is further clarified over time, and we must be prepared to change procedures, when necessary. It is great that someone is constantly screening the EU news and pin-pointing key factors which affect our practical work. – Eriikka Heikkinen
Expertise for the safety of patients
Implementing the requirements of the new EU Regulations improves patient safety and clarifies the responsibilities of the various operators in the distributor chain. Distributors and importers have a more defined responsibility for ensuring the compliance of IVDs and MDs marketed in Finland. This situation further highlights the importance of companies’ regulation and quality expertise. Triolab has prepared for the regulatory reform for a long time and will continue close cooperation with the manufacturers.