On May 25th 2017, the new European Medical Device Regulation has been enforced and is replacing the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC).
One year from now, you need to have updated your technical documentation and processes to meet the requirements. These changes combined with a complex development process for medical devices make the transition a complicated and time-consuming process. Therefore, it is critical for companies marketing devices in the EU to begin as soon as possible.
What you need to know about EUDAMED
You need to comply with regulatory requirements as per the European Union regulatory requirements for medical devices, this includes the registration of all medical devices in EUDAMED
- All medical devices sold in the EU are affected
- The European Commission has set a short and strict deadline
- The time window to register your UDIs in production is only April – May 2020 – we can help you way ahead of this deadline to prepare and validate your product content
How we can help you comply with EUDAMED
- 1WorldSync will be the first solution that will be tested by the EU Commission in Q3 2019
- We can provide validated environment already in 2019, where suppliers are able to upload their data and test it, before the deadline, as per the EUDAMED requirements
- You will have time to upload and test before the uploading time window in 2020 (April-May)
- We will ensure six months of additional time to prepare your data for the deadline
- Our close relationship with the European Commission and the MedTech industry allows us to enable compliance
- Our solution can also be used to share trusted product content with other trading partners (such as hospitals & GPO) and other regulatory bodies, such as the FDA (GUDID)