On May 26, 2021 the Medical Devices Regulation (MDR) entered into effect after a four-year transitional period. The MDR will introduce various changes that will have an effect on the supply chain for medical devices and will therefore have an impact on all the relevant market parties, including manufacturers, importers and distributors of medical devices, healthcare providers, patients and other economic actors within the medical devices industry.
On May 26, 2021 the Medical Devices Regulation (MDR) entered into effect after a four-year transitional period. Initially, the MDR was to become fully applicable on May 26, 2020, but the date of application had been postponed by one year due to the Covid-19 pandemic.
The MDR will introduce various changes that will have an effect on the supply chain for medical devices and will therefore have an impact on all the relevant market parties, including manufacturers, importers and distributors of medical devices, healthcare providers, patients and other economic actors within the medical devices industry. Spearheads of the MDR include amongst others:
- A life cycle-approach regarding medical devices
- Stricter ex-ante control for high-risk devices
- A new risk classification system for medical devices
- More transparency and better traceability of medical devices, following the introduction of the Eudamed database and the Unique Device Identifiers (UDI)
- Appointment of a person responsible for regulatory compliance (PRRC)
The MDR has also revised the definition of a medical device. Indeed, implants and reagents are now specifically included under the new definition. Furthermore, a group of devices without an intended medical purpose (but similar to medical devices due to their functioning and risk profile) is now included in the scope. Examples of such devices include contact lenses, cosmetic implants and fillers. Medicines, blood(products), cosmetics and food are excluded.
On a related note: because of the Covid-19 pandemic, the European Commission and, on a national level, the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd) have granted some temporary exemptions in relation to, for example, early market access for personal protective equipment without CE marking.
Are you a manufacturer, distributor or importer and would you like to know what (additional) obligations or temporary exceptions apply to you under the new regulation? Please do not hesitate to contact us. We would be happy to assist you.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
