Compliance with MDR
The Medical Device Regulation (MDR, Regulation (EU) 2017/745) constitutes the European Unions’ regulatory framework for medical devices.
The MDR sets high standards of quality and safety for medical devices in order to meet common safety concerns. This ensures a high level of protection of health for patients and clinicians.
All medical devices need to be compliant to the EU MDR before they can be placed on the EU market. The EU MDR defines a 3-year transitional period before implementation in May 2020.
Class I Medical Devices need to be compliant by 26th May 2020.
Class Ir, Is, IIb and III devices require issuance of EC certificates to the EU MDR.
Medical devices covered by an existing EC certificate under the MDD can continue to be placed on the market until the expiration date of the certificate, but not later than May 2024.
Like all responsible manufacturers of medical devices, STERIS is working to make sure that our products and processes comply with the expanded requirements of the EU MDR.
Especially in key areas including:
Device classifications
Technical documentation and labelling
Clinical evaluations
Quality management system/vigilance and post market surveillance
UDI and data reporting
New legal responsibilities for economic operators
If you have any questions regarding MDR compliance, contact us on sterisims_enquiries@steris.com
