MDR class IIa

This is the culmination of several years of work – a journey that has been wonderfully challenging and exhausting. Stretch Care has worked hard over a long period on quality and patient safety. The certification is an important milestone in this journey.

MDR – EU Medical Device Regulation

Medical devices are primarily regulated by the EU regulation called MDR (Directive 2017/745). Systems that perform calculations on medical records and are part of the care chain for an individual patient normally need to implement MDR (very simplified). A major difference compared to the older MDD is that MDR practically means that all digital systems become class IIa (or higher), which in turn requires an external certifier (so-called notified body, which in our case is TÜV SÜD).

The regulation came into effect in May 2021. Products similar to Amnicare, which were certified under MDD before that, had until May 2024 to complete MDR. This date has recently been postponed to May 2027 (under certain circumstances), but our goal has always been to be ready well before 2024, which we have now achieved.

ISO 13485

MDR places, among other things, requirements on a quality system, which in practice is based on ISO 13485. Read more about our ISO 13485 certification here:

ISO 13485

Questions?

Feel free to contact us if you have any thoughts or questions about our ISO standards and quality processes.