New legislation on medical devices – MDR
From 26 May 2021, it will be compulsory in Europe to comply with the new MDR regulations.
MDR stands for Medical Devices Regulations. These new European rules for medical devices ensure increased patient safety in all countries of the European Union. All medical devices must meet these strict requirements to qualify for market authorisation and to remain available to patients.
More transparency for patients and better traceability
MDR has been set up, among other things, to achieve better track and traceability of implants and certificates of equipment and other medical devices. Healthcare professionals and patients will have access to information about medical devices via a European database (EUDAMED).
To replace the current legislation
The new rules consist of two regulations, one for medical devices (MDR) and one for in vitro. The European Commission announced the introduction of two new regulations for medical devices, which would replace the three existing directives for medical devices: IVDMD1, MDD2 and AIMDD3.
Are your labels MDR-ready?
It is best to start the changeover in time. May 26, 2021 is in a sense far away but also very close.
Codipack Group already has the know-how, expertise and the necessary software to adapt the design of your labels.
Ask the advice of your MDR specialist at Codipack Group. Contact us at email@example.com
All details about this regulation and the software that can help you with the implementation can be found in this white paper.
Download your free test version here.
Frequently asked question: Do wristbands fall under the new MDR regulations?
No, wristbands do not fall under medical devices. It is an aid in a hospital, but is not intended for medical treatment or intervention.