In July 2021, a new Medical Devices Act (MPG 2021) came into force in Austria that sets out new obligations and requirements for players in the medical devices market. However, it only covers those legal areas not already regulated at EU level by the Medical Devices Regulation, which has been in force since 26 May 2021. For in vitro diagnostics, such as Covid-19 or pregnancy tests, the old Medical Devices Act will continue to apply until the EU In Vitro Diagnostics Regulation becomes applicable on 26 May 2022.
MPG 2021: Overview of the main innovations
The MPG 2021 regulates the various stages of the “life cycle” of a medical device. For example, it contains new requirements for clinical studies, a registration obligation for distributors and for manufacturers of custom-made devices, regulations on language requirements and on in-house devices. Violations of medical device regulations are sanctioned by comprehensive administrative penalties, and now even an attempt to violate the law is punishable.
The requirements of the Medical Devices Regulation apply to clinical studies conducted to demonstrate a device’s conformity. The MPG 2021 therefore only concerns clinical studies that do not serve to demonstrate a device’s conformity. If they have an impact on the diagnostics and/or therapy of a trial subject, then they require approval by the Federal Office for Safety in Health Care (BASG). Other studies must only be reported to the BASG. The sponsor must also notify the medical director of the hospital where the clinical trial is to be carried out. Moreover, the sponsor must ensure that trial subjects have a contact point from which they can obtain information.
If the reporting or approval requirements of the EU regulations or the MPG 2021 are not complied with, far-reaching consequences are now provided for: the data obtained may not be published, may not be passed on to third parties either against payment or free of charge, and may not be used in the context of a conformity assessment procedure or an approval procedure. In addition, publications that have already been made must be withdrawn.
Registration obligation for distributors and for manufacturers of custom-made devices
Whereas distributors previously only had to register in the Austrian medical device register when first placing medical devices on the EEA market, the MPG 2021 establishes a general national registration obligation for distributors and for manufacturers of custom-made devices. Although the corresponding provision has already entered into force, the body responsible for registration is yet to be decided. It can be assumed that Gesundheit Österreich GmbH will assume management of the register, as it already operates the Austrian Medical Devices Register. Distributors have already been able to register in this register, albeit on a voluntary basis.
New language obligations have also been introduced. The following information and documents must now be provided in German:
- he information accompanying the medical device (for professional users, English is sufficient);
- EU declaration of conformity at the request of users or patients;
- documents proving conformity at the request of the BASG;
- information enclosed with implantable devices;
- field safety instructions.
Advertising for medical devices continues to be regulated at national level. Essentially, the previous regulations have been adopted here – the options for advertising to laypersons remain severely restricted.
In addition to the detailed national provisions, Art. 7 of the Medical Devices Regulation provides for a uniform ban on misleading advertising concerning medical devices for the first time at EU level. This goes beyond the previous national regulations in some areas. For example, it can be misleading if the user or patient is not informed about the expected risks associated with the use of the device in accordance with its intended purpose. Previously, the Austrian MPG contained no such regulation.
The MPG 2021 contains no ban on the manufacture and use of certain in-house devices in healthcare facilities, as originally planned, but rather an authorisation to issue ordinances. The competent Federal Minister may, by means of an ordinance, specify in-house devices that may not be manufactured or used in healthcare facilities. Furthermore, requirements for in-house production may also be specified in this way.
What applies to old devices?
Certificates for medical devices issued by notified bodies after 25 May 2017 (but before the new legal situation came into force) in accordance with the EU Directives applicable at that time remain valid until the end of the period specified therein – however, they lose their validity on 27 May 2024 at the latest. Furthermore, medical devices that would now, due to the amended legal situation, be subject to a conformity assessment procedure with the involvement of a notified body, but for which an EU Declaration of Conformity based on the old legal situation already exists, may continue to be placed on the market. However, such medical devices must still comply with the requirements of the EU Directives and no significant changes may be made to the design or intended purpose. It should also be noted that old devices are also subject to the new regulations on post-market surveillance according to the EU Medical Devices Regulation.