On 26th May 2021, Europe implemented stricter rules for medical devices (MDR) aiming to give patients more clarity and enabling them to make a better and well-informed choice. The new directives have consequences for manufacturers, importers, distributors and care providers.

Well-informed choice

Patients and health care professionals gain access to EUDAMED, the European Database on Medical Devices. This database contains information about medical devices and manufacturers, for example the CE marking, clinical research and instruction manuals. An important goal of the new ruling is to inform patients better, allowing them to choose the medical device best suited to their needs.

Consequences for manufacturers

Under the new regulation, several medical devices have received a higher risk classification, meaning those devices need to meet higher demands before you can market them.

Are you a producer or manufacturer and need help navigating the new rulings and its implications for you? Do you need a clinical evaluation, clinical evidence or a performance study?

Get in touch today on +31384262999 or info@diagram-zwolle.nl, the first batch of Diagram employees received their ‘MDR | Medical Devices and ISO14155’ certification and are ready to support you.

Read more here:

https://www.rijksoverheid.nl/onderwerpen/medische-hulpmiddelen/nieuwe-wetgeving-medische-hulpmiddelen (in Dutch)

https://business.gov.nl/sector-specific/care-and-animal-care/medicines-and-medical-technologies/medical-devices-mdr-and-ivdr/

In Depth ISO14155 2020 Certificate of Completion Sonja Postma
ISO 14155:2020 Certificate of completion