HIBCC Industry News
Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.
As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.
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European Commission delays its MDR by one year to focus on the Coronavirus, but leave labeling and database compliance deadlines unchanged.
March 25, 2020 the European Commission announced that they are working on “a proposal to postpone the date of application of the MDR for one year”. The proposal is expected to be submitted to the European Parliament in early April. The postponement seeks to “temporarily alleviate the burden on available resources” in the healthcare industry.. read more →
As the outbreak of the Coronavirus (COVID-19) continues to rapidly evolve, HIBCC remains focused upon playing its part in ensuring that necessary medical devices and pharmaceuticals will move through their supply chain unhampered. HIBCC’s Health Industry Number (HIN) is used by the vast majority of pharmaceutical and medical device suppliers to facilitate the necessary “electronic.. read more →
HIBCC has released a new page on the www.hibcc.org website for how to utilize HIN for the Drug Supply Chain Security Act (DSCSA). The page will be regularly updated with HIBCC guidance for satisfying DSCSA requirements. To view the page click here. To learn more about how HIBCC and how the HIN System can be.. read more →
The European Commission released the third version of the Medical Device Coordination Group’s (MDCG) “Guidance on Basic UDI-DI and Changes to UDI-DI” document. The new version includes additional information on devices that are directly marked and the manner in which the production of the device is controlled. To view the updated guidance document click here… read more →
HIBCC Presentation “Using Health Industry Number (HIN) Tools for 340B and DSCSA” Now Available Online
Download the full HIBCC Presentation. Event Name: 2020 Distribution Management Conference and Expo To learn more about HIBCC and the HIN System, visit www.hibcc.org or contact HIBCC directly at email@example.com or +1 (602) 381-1091. read more →
HIBCC has consolidated its various points of contact to assure uniform compliance with the European Union and the US FDA UDI regulations, for which we have been designated as the Issuing Entity and Issuing Agency respectively. Accordingly, we have assumed all LIC assignment and maintenance responsibilities. Labelers are asked to direct their communications and inquiries.. read more →
- 09 Jun 2021EC publishes FAQ on the European Medical Device Nomenclature
- 19 May 2021EC publishes guidance addressing MDR requirements in the event EUDAMED is not fully functional
- 25 Mar 2021Is your software considered a medical device under the EU MDR/IVDR?
- 15 Mar 2021EC publishes MDR guidance on Custom-Made Devices
- 17 Feb 2021Register now for our HIBCC EU UDI Webinar