After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A lot of uncertainty is still associated with this date and key stakeholders are still questioning the readiness of the system. Twenty notified bodies out of fifty applicants were already designated for this legislation, more than sixty guidance documents clarifying the wording of the regulation were published and partial implementation of EUDAMED was achieved, but is it enough to ensure smooth transition from the old directives to the new legislative framework?
It is positive to see twenty designated notified bodies for this legislation that are committed to support its implementation by continuously hiring and training new resources ensuring sufficient capacity for the various scopes necessary. Nevertheless, we should not forget that more than 80 notified bodies were available in 2012 and the system was not able to deliver predictable assessment and certification decisions. With the requirement for initial certification of all devices regardless of their market history, the prerequisites written in Article 120 and especially the expectation on notified bodies to apply appropriate surveillance ensuring continuous compliance of directives´ certificates during the grace period of the regulation from May 2021 till May 2024 it remains questionable if the current capacity will be sufficient. Therefore, it is key to start applying practical and reasonable interpretation avoiding additional burden on the notified bodies who are struggling to keep on track with the continuous changes and implement the requirements in a timely manner.
Also positive is the publication of the huge number of guidance documents supporting notified bodies and manufacturers implementing the requirements. Nevertheless, we still miss key guidance documents and common specifications which are essential for the implementation of the regulation (e.g. appropriate surveillance, article 16 requirements, substance based medical devices and the common specification for medical devices without intended medical purpose). A clear rule explaining the legal status of the guidance documents and providing a transition period for their implementation would be very helpful for all impacted parties. Notified bodies are forcing the implementation of these guidance documents without any transition period since they are pushed in that direction by the relevant designating authorities. Manufacturers are not able to switch a system from one day to another, a realistic and patient oriented approach is essential.
Finally, it is motivating to see the efforts of all medical device companies who are doing all possible to ensure continuity of the healthcare system in Europe by preparing EU MDR compliant quality management system and technical documentation. As mentioned, they are doing their best, but they are also struggling like other stakeholders since a huge number of questions is still open and they are continuously surprised by new or different interpretations of their notified bodies or surveillance authorities.
In summary, we can clearly see the commitment of all stakeholders towards the healthcare system and the patient who is getting the main benefit from safe and effective devices. Nonetheless, we need to accept the fact that the regulation remains new and under continuous clarification even after 4 years of publication. The same experience was done with the directives and we cannot expect fully clearly regulation from day 1. Therefore, it is important to avoid black on white implementation, to apply the risk-based approach principles and to keep the patient centric in all what we are doing.