On May 26, 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices entered into force in the EU, MDR, and on May 26, 2022, the Regulation for in vitro diagnostic devices and systems (EU) 2017/746, IVDR, followed. The new medical device regulations have been followed by new laws at national level, introducing many new and extended requirements for both manufacturers and users. More specifically, in cases where the user takes over the responsibility from the manufacturer or takes on the role of a manufacturer in the form of self-manufacturing of medical devices and in vitro diagnostic systems.
What does the European Commission say with reference to MDR and IVDR?
"Healthcare professionals need to be aware that the Regulations are more stringent than the Directives: in general they retain the existing requirements and add new ones. The Regulations emphasise a life-cycle approach to safety, backed up by clinical data."
"The Regulations introduce new rules for in-house devices, custom-made devices, clinical investigations, reprocessing of single-use devices, and distance sales. They also require implant cards for patients. They strengthen the rules for the designation of notified bodies - the independent evaluators of manufacturers and their devices." More about the regulation can be found here.
Do you need support?
Med vår breda och gedigna kunskap inom medicinteknik, både utifrån medicintekniska produkter och in vitro diagnostiska system kan vi stötta dig, oavsett i vilken omfattning du har behov av. Lite eller mer, längre eller kortare. Vi finns där du behöver oss. Vi stöttar både privata och offentliga aktörer i allt från diskussions- och planeringsfaser, är praktiskt partner för utförande och operativt arbete eller som rådgivande part i form av specialistresurs för specifika frågor. Oavsett vilken behovsnivå just du har, kan vi guida dig framåt.
Issues and solutions where we support our healthcare clients in:
- What do the new rules mean for healthcare providers?
- How do we get started? - Seminars and workshops.
- Gap analysis between existing work processes and new requirements.
- Support in the practical use of standards.
- Consolidation of in-house produced products or practical work to inventory and compile technical documentation.
- Specialist resource for quality management system compliance.
Training and seminars
We are partners with the Swedish Medical Technology Association, Swedish Medtech and Swedish Labtech and Läkemedelsakademin (The Swedish Academy of Pharmaceutical Sciences). Through the Academy we offer a large number of courses both together with our partners and tailored directly to businesses. We also offer workshops in IVDR and MDR.
