Safe Patient Care Through Safe Technology

In May 2021 the new EU legislation took effect for medical devices, and from May 2022 for IVDs (in-vitro diagnostics, or laboratory tests, materials and equipment). Doctors’ assistants, anaesthesia technicians, nurses, ICT staff, laboratory staff, medical technicians, purchasers, researchers and medical specialists: the vast majority of healthcare professionals will ultimately have to deal with this legislation in one way or another. What does this new legislation mean concretely for patient care and clinical research in the umcs?

Why is the legislation being changed?

The new European legislation is striving to increase the safety and effectiveness of medical devices and IVDs. This will prevent the situation of patients having to deal with, for example, poor-quality breast implants or unreliable lab tests. The rules which these products must comply with have been made stricter, and after a transition period, they came into effect from May 2021 (MDR) and May 2022 (IVDR).

What will we notice of the change?

The new EU rules may lead to the consequence that certain devices and IVDs will no longer be available in the future. Alternatives will have to be sought. It is also possible that self-developed tests may no longer be used if the manufacturer produces a comparable laboratory test.

In addition, the rules are changing for the clinical research of medical devices. Patients who need a particular implant must be given an implant chart. Who is going to ensure that the new rules will be followed? A solution is currently being sought for all these issues.

What do we do in the program?

Since September 2019 a group of experts from the umcs (supplemented with experts from general hospitals and representatives of the Federation of Medical Specialists) have worked in the NFU program on preparations to implement the new legislation efficiently and effectively. They charted which changes healthcare institutions will face due to the new laws. The experts then described these changes in terms of proposals. They offer starting points for applying the rules in practice; they do not provide a ready-made implementation plan. Currently, all umcs are working on applying the proposals so they comply with the new legislation from May 2021 and May 2022, respectively.

The following proposals are available:

• Overarching start document;

• Traceability of medical devices;

• Clinical scientific research;

• Software;

• Deviations in manufacturer’s instructions for medical devices;

• In-house development of medical devices;

• Hospital as manufacturer (an extension of in-house development);

• Post-market surveillance.

For IVDs the manual of the national IVDR taskforce is used.

The proposals are available for use within the umcs and the general hospitals. The umcs are acting jointly on the implementation. Within each umc an implementation team is active. In addition, collaboration is done in theme teams, within which the members share experiences and best practices. The general hospitals follow their own procedure for implementation.