In a world of regulatory compliance, there has never been a more important time for the healthcare industry to address product information management. Patient safety, medical device traceability, and government regulations are having a profound effect on product information within the healthcare industry.
The demands are growing and it is essential that healthcare companies find a comprehensive and cost-effective approach to manage, collect, validate and distribute information.
EUDAMED Launch And Beyond
With the launch of EUDAMED now only 19 months away, the European Commission and MedTech Europe expect that the industry has to move quickly to be compliant with the 2020 deadlines. Roughly 10 customers of 1WorldSync have reacted to the call for volunteers from the EU Commission to test the M2M connector to EUDAMED at the end of Q1 2019.
After the completion of this testing process, 1WorldSync expects to have an environment available for manufacturers (target date: summer 2019), for them to start uploading UDI product content and checking it against EUDAMED validation rules quite ahead of the EUDAMED production go-live date in March 2020.
As mandatory compliance deadlines have already been announced by the NHS in the UK, as well as some leading GPOs, hospitals, and clinics in countries like Germany, France, the Netherlands, and Spain, with more projects maturing like in Switzerland or in Belgium, the time to act is now!
In Europe, 1WorldSync, the leading provider of trusted product content, has initiated activities to support manufacturers in how to best comply with the increasing demands from regulatory bodies and trading partners. Other global activities include:
- In the United States, 1WorldSync initiated a pharma GDSN pilot project where we provided the technology used by the participants.
- 1WorldSync is reacting to the new regulation that China is currently drafting regarding UDI and Product registration
Generating Value Beyond Compliance With 1WorldSync
1WorldSync offers discovery workshops in Europe to:
- Teach companies how to be compliant with MDR/EUDAMED
- See which GDSN projects companies should focus on in the short term in Europe
- Educate organizations on exchanging product content leveraging GS1 standards with trading partners.