The operations of the pharmaceutical wholesale is strictly regulated and controlled through legislation, regulations and regulatory provisions. Tamro's experts are actively keeping an eye on the development of the legislation that covers our operations. In this article, we review the future changes to medical device legislation and how they affect Tamro's operations.
The legislation on medical devices will change in the EU on 26 May 2021 with the application of the MD Regulation 2017/745, which entered into force in 2017. By a Commission decision, the application of the regulation was deferred by a year from the initial transitional period of three years due to the coronavirus situation. The application of the In Vitro Diagnostic Regulation 2017/746 on handling of in vitro diagnostic medical devices will begin after one year, on 26 May 2022.
The new regulations will harmonise the legislation and supervision of medical devices within the EU, as the differences arising from national interpretations will be eliminated. Country-specific laws drawn up for the application of the old directives will be replaced with the new EU-level legislation. The new regulations will make the requirements of the old directives more effective, but they also involve new factors that improve the transparency of the industry and the traceability of products.
MDR = Medical Device Regulation
IVDR = In Vitro Diagnostic Regulation
UDI = Unique Device Identifier
EUDAMED = European Database on Medical Devices
Stricter control on the placing on the market of medical devices
Above all, the aim of the new legislation is to improve clinical product safety and to promote the health of the people using medical devices. For example, the device classification criteria will be renewed and the validation of the monitoring processes of the notified bodies will change. The post-market surveillance requirements for medical devices will become stricter and the pre-market control of high-risk devices will be strengthened. All in all, the requirements applied to medical devices will become more aligned with the quality and safety requirements applicable to medicinal products. Product traceability will be facilitated by the redesigned EUDAMED database on medical devices as well as the UDI system, including the introduction of a unique device identifier, especially for high-risk devices.
Changes to the arrival inspection and customer order picking of devices
The transitional period for the new legislation will in part extend to May 2025, which may confuse the actors within the industry. Devices complying with the old directives dating back to the 1990s and devices certified in compliance with the requirements of the new legislation will both be available in the market at the same time.
The new legislation also brings changes to Tamro's operations. Tamro's role is that of a distributor. In order to ensure that liability issues are clear to everyone and that the requirements of the authorities are met, we have drawn up a contract appendix and been in contact with all our medical device suppliers about it. On a practical level, changes will be made, for example, to the arrival inspection of medical devices and to customer order picking. Tamro has also created the ability to process and register UDI data in compliance with the requirements of the new regulation.
We are happy to have an open dialogue about the subject with the various actors in the industry. Different perspectives and interpretations are welcome for all of us who are pondering the practicalities of the application of the more than 100-page regulation.