Medical Device Regulation MDR: Postponed is not canceled

Medical devices such as artificial hip joints or silicone breast implants have repeatedly come under scrutiny in the past: defective products - for example, several patients had to have leaking silicone breast implants removed again - caused uncertainty among both doctors and patients. Not only were the manufacturers of qualitatively questionable products pilloried, but also the testing bodies that had given these products the CE seal of approval. Various claims for damages, e.g. by affected patients because of the leaking silicone pads, are currently still pending before the courts.

Legislation in the service of patient safety

Naturally, politicians also began to take notice. As early as 2012, the EU Commission presented draft regulations focusing on medical devices (Medical Devices Regulation, MDR) on the one hand and in vitro diagnostics (In Vitro Diagnostic Medical Devices Regulation, IVDR) on the other. The aim was to improve the quality and safety of medical devices and consequently to increase patient safety. This goes hand in hand with stricter regulatory requirements. For example, manufacturers must be able to submit even more detailed clinical evaluations for all their products than before. This often requires their own clinical studies. In addition, manufacturers must regularly prepare safety reports on their products. The list of medical devices that must be tested by assessment bodies has also been expanded. And the assessment bodies, unlike in the past, must meet additional requirements. Last but not least, clear identification as well as complete traceability of the products must be ensured. The relevant data are available to the public in a newly created database (EUDAMED 3).

Corona upsets timetable

The regulations were adopted by the EU in 2017 and should now finally come into force in May 2020 after the expiry of various transitional periods. As a result of the Corona crisis, however, the EU Parliament has decided to postpone the date of application of the MDR by one year to 26 May 2021. This does not affect the IVDR, which is scheduled to apply from spring 2022. What does this mean for Switzerland with its strong and export-oriented medtech sector? As is well known, Switzerland and the EU have an agreement on the mutual recognition of conformity assessments (MRA). This means that Swiss legal regulations must be equivalent to those of the EU. In this context, Switzerland has also brought forward the revision of the Medical Devices Ordinance (MepV). The Therapeutic Products Act (TPA) and the Human Research Act (HRA) were also amended to ensure conformity with EU law. Originally, according to the Federal Administration, the amendments to the HMG and HRA adopted by Parliament in March 2019, as well as the ordinances, should have entered into force on 26 May 2020. With regard to the next steps, the website of the Federal Office of Public Health (FOPH) states that for "reasons of coherence" the "entry into force of the new provisions in Switzerland will be gradual". The exemptions for the placing on the market and putting into service of medical devices that have not undergone a conformity assessment procedure have been in force since 1 August 2020. This will make it possible, if this is in the interest of public health, to also allow the placing on the market and putting into service of medical devices without a conformity assessment. And the FOPH goes on to write: "The most important provisions, which concern, among other things, the requirements for placing on the market, market surveillance or the new requirements for clinical trials, will enter into force on 26 May 2021."

Close last gaps

The Swiss medtech industry is now gaining time to better prepare for the EU regulation. A survey by the industry association Swiss Medtech showed that 28 percent of Swiss manufacturers would not have been ready for the original date of application of the MDR. However, the majority of the industry should be able to make the switch by May 2021. Until then, however, there is still legal uncertainty: from an EU perspective, Switzerland is currently a "third country" because it has not yet updated its mutual recognition of conformity assessment. Swiss Medtech is therefore calling on the Federal Council to quickly update the MRA. "Medical technology is a healthy and innovative industry with great economic importance. Switzerland is one of the world's most attractive medical technology locations. The continuing legal uncertainty poses a massive threat to investment attractiveness. We expect the Federal Council to do everything in its power to maintain direct access to the EU internal market," says Peter Biedermann, Managing Director of Swiss Medtech. What is now required is the Switzerland-EU Joint Committee, which negotiates the MRA in each case and lays it down in international law. The State Secretariat for Economic Affairs (Seco) is in charge of this process.

ISO standard takes account of new regulation

Medical devices and their clinical trials are highly regulated. Manufacturers are assisted by the recently revised ISO 14155 standard (Clinical investigation of medical devices for human subjects - Good clinical practice). The standard, which is widely used throughout the industry, has been adapted to reflect recent regulatory changes and amendments to other relevant standards. It now includes a variety of additional details and information to help protect clinical trial participants and users of medical devices and achieve sound outcomes, according to ISO. A particular focus, for example, is on risk management throughout the trial period by describing a close relationship of ISO 14155 to ISO 14971 (Medical devices - Application of risk management to medical devices). A reference to the obligation to register the clinical trial in a publicly accessible database has also been included, as well as the inclusion of clinical quality management and risk-based monitoring. Danielle Giroud, spokeswoman for the ISO expert working group that developed the standard, said patient safety is always the focus. "This means more detail on aspects such as informed consent, vulnerable populations, privacy and statistical considerations, all leading to safer clinical investigation with more robust evidence."