The European Medical Device Regulation [2017/745] (EU MDR) is a new framework of regulations outlining the requirements medical device manufacturers must satisfy to obtain CE marking and market their products in the European Union (EU).
What is the aim of the EU MDR?
The new regulation aims to enhance the safety and quality of medical devices in the EU by increasing the scrutiny of medical devices throughout the entire life cycle – from design and development to post-market surveillance. Additionally, it reinforces the governance and oversight of notified bodies responsible for assessing the conformity of devices before they can be legally marketed in the EU.
Download our EU MDR 2017/745 position statement and guide to Annex II
When does the EU MDR become enforced?
The EU MDR was officially published on May 5, 2017, and became effective on May 25, 2017. It mandates that all newly manufactured medical devices intended for sale in the EU must comply with the EU MDR requirements.
What about current products with CE marking?
The EU MDR (2017/745) replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD).
For medical devices that received CE marking under the MDD or AIMDD, manufacturers must re-register their medical device under the EU MDR. However, a transition period has been put in place for re-registration, which has been extended to 2027 and 2028. The extended transition period aims to prevent the unnecessary disposal of safe devices, therefore avoiding potential shortages of medical devices and safeguarding the quality of healthcare services.
If I am developing a new medical device, what regulations do I need to meet?
Any new product development will need to meet the EU MDR / EU IVDR requirements to be able to obtain the CE mark and to sell within the EU.
Where can I get the additional information needed by the EU MDR?
As a responsible distributor of single-use, non-sterile components, Qosina strives to assist our customers with regulatory filings and simplify the integration of our components into your medical device. To provide guidance on the EU MDR [2017/745] Annex II requirements, we have created a comprehensive position statement outlining the relevant documentation for each section. You can download the position statement directly from this page. Please note that not all the requested information is made available by every supplier. Any information we receive is available to you for download on the product page or at www.qosina.com/resources at your convenience.