The EU Medical Device Regulation (MDR) came into force in May this year. The MDR differs greatly from the previous medical devices directives and is posing some major challenges for medical technology companies and their suppliers such as Roth.
The new EU Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) on 26 May 2021. The requirements under the MDR are considerably stricter than those under the preceding directives. This is because of various scandals in the medical technology industry (e.g. contaminated hip implants and leaking breast implants) and subsequent calls for more patient safety.
Clinical evidence and unique identification
What are the main changes under the MDR? Firstly, the regulation’s scope of application has been extended to other product groups, such as aesthetic implants. Secondly, the MDR requires clinical studies to be more comprehensive. Thirdly, each product must be given a UDI (unique device identification) number for traceability purposes. Last but not least, products will be subject to stricter post-market surveillance.
Patient safety versus continued supply
While everyone agrees that patient safety must be ensured, the MDR is seen as disproportionate by many medical technology companies. Under the new MDR, medical devices that have already been approved will need to be assessed again and re-certified by 2024. Because this will involve a considerable amount of time, money and effort, many manufacturers (especially SMEs) are being forced to withdraw their products from the market. In addition, notified bodies are experiencing capacity shortages, as they also have to be re-accredited under the new legislation. All of these developments are jeopardising patient safety.
No recognition despite equivalence
The completely revised Swiss Medical Devices Ordinance (MedDO) came into force at the same time as the European Union’s MDR. The MedDO is heavily based on the MDR, which further ensures equivalence between the Swiss and EU laws on medical devices. However, due to the failure of the framework agreement between Switzerland and the EU, there is no valid mutual recognition agreement (MRA) for conformity assessments. Products that are to be sold both in the EU and Switzerland therefore have to pass two separate approval processes.
Although the intentions behind the new MDR are laudable, it is simply not practical for many SMEs or for niche products. We would like to see fewer bureaucratic hurdles and longer transition periods, so that greater patient safety does not have to come at the expense of patient care and innovation. At the same time, an MRA between the EU and Switzerland is urgently needed in order to avoid unnecessary duplication of effort.