ARE YOU READY FOR
THE EU MDR?
The deadline to the EU Medical Device Regulation directive is approaching.
Are your IFUs compliant with the new requirements?
MAY 26, 2017
EU MDR Published and Entered into Force.
NOV 26, 2017
Notified Bodies may apply for designation according to the EU MDR.
MAY 26, 2020
MDR date of Application. EC Certificates of Conformity issued before May 26th, 2017 will expire.
MAY 26, 2022
EUDAMED will go live.
MAY 26, 2024
Notified Body certificates issued under AIMDD and MDD designation become void.
MAY 26, 2025
Devices certified under the AIMDD and MDD can no longer be sold or distributed.
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The existing regulatory framework has been in place for nearly 30 years. It has been amended on an ad hoc basis in that time, but pressure to modernize it in order to better address risk management and guarantee the continued safety of medical devices sold in the European Union has has been growing.
As a result, the European Commission presented two legislative proposals in September 2012, which were followed by five years of consultation and negotiation that concluded with a new set of regulations affecting manufacturers, distributors, notified bodies, importers, suppliers, and member states.
March 26, 2020
- One of the key developments related to the new regime is the creation of EUDAMED, a database for all Medical Devices sold to European markets.
- Non-medical and cosmetic devices that were not classified as medical devices will now be added to the list. Also, medical purpose devices and AIMD are both included under MDR.
- Unique device identifiers (UDIs) will be placed on device labels to provide traceability.
All existing CE marked products will need to be recertified against MDR to retain the CE mark and continue to sell products in the EU.
The EU MDR does not distinguish between lay use and professional use with regard to requirements for device design, manufacturing, risk, or safety.
Depending on marketing and distribution objectives, some products may require the translation of content in up to 24 languages. In addition, there can be more than 20 information pieces required for each product label or IFU, depending on classification.
Working closely with a translation and localization provider who specializes in medical language services and is ISO registered is an important step in conquering the ever-changing international regulatory process. The choice of translation provider is critical in order to guarantee that translations are accurate, consistent, and technically correct.
Click here for more information about our Medical and Healthcare Translation Services.