Balancing Act: Taking a Harmonised Approach to Medical Device Label Interoperability

In this interview Melissa Finocchio, Director, Product Labeling and Documentation BioMerieux, speaks to Andrea Charles from Pharma IQ about changing trends in product labelling and documentation for medical devices, overcoming barriers to standardisation and BioMerieux's top 3 priorities for 2014 now that the FDA Final Rule on UDIs for medical devices is out.

Download the UDI Final Rule Interactive Compliance Calendar!

The FDA Final Rule on unique device identification (UDI) for medical devices is out. Covering both labelling and the GUDID database, manufacturers need to assess their current technical capabilities - both hardware and software - and work out how much they need to do in order to comply.

Click Here to Download

Featured Speakers :

European Commission
Laurent Selles
Deputy Head of the Cosmetics and Medical Devices Unit
European Commission
FDA
Indira Konduri
GUDID Program Manager
FDA
GS1 Global Office
Ulrike Kreysa
Vice President of Healthcare
GS1 Global Office
EHIBCC
Heinrich Oehlmann
Chairman
EHIBCC

**Please read this letter
from our Chair**


Comply with new international regulations, understand the financial & time impact on your business and develop a strategy for practical implementation of UDIs & traceability

Europe's only UDI-dedicated event for the medical device industry, with keynotes from the FDA and European Commission


Well the FDA Final Rule on UDIs for medical devices is out. Covering both labelling and the GUDID database, manufacturers need to assess their current technical capabilities - both hardware and software - and work out how much they need to do in order to comply.

At the Munich UDI meeting last September the European Commission also announced their intention to follow suit, potentially as soon as this year (2014).

So what does this mean for industry?

Well it means that imminently, medical device manufacturers will have to upgrade their labelling & packaging systems along with their data management capabilities in order to stay compliant with incoming regulations.

Select which best applies to your products:

- Class I
- Class II or III




Class I



By now your deadline is looming imminently - your US operations should already be compliant with the Final Rule. The task is not over, however - it is your responsibilty to ensure you remain compliant, and to do so in the optimum way. Could you be saving money? Could you be more efficient? You've had to move pretty quickly to get up to speed with the FDA Final Rule, so inevitably there will be many opportunities to save time and money.

On the 20-22nd May 2014, project owners and senior leaders from medical device manufacturers, regulators, hospitals and key stakeholder groups will meet at the Medical Device UDIs and Traceability Summit in order to discuss real, practical solutions to many of these challenges with peers who are in the same boat. This meeting will provide a platform to benchmark against and learn from those manufacturers who have already begun this transformation, and to understand how it will affect the hospitals that make use of our devices – as well as an opportunity to meet some of the suppliers that can help with the implementation of UDIs and traceability technology.

  • Understand what impact the September 2013 FDA Final Rule on UDIs will have on your business
  • Gain clarification on the European Commission's UDI Roadmap and it's intent to maintain an international, harmonised approach in Europe to UDIs with the FDA
  • Ensure compliance with new international regulations and legislation whilst still complying with existing supply and distribution regulations, across different countries and continents
  • Discover the financial and time cost-impact UDIs are going to have on your business - how much will UDIs cost you? What do you need to do? When do you need to start?
  • Learn from other manufactuers who have already implemented part of the UDI set-up in their supply chain traceability models - what are the pitfalls to avoid?
  • Realise the additional business benefits of implementing UDIs beyond simply regulatory compliance and supply chain visibility
  • Benchmark and network with your peers and competitors who are all facing the same challenges you are





Class II / Class III

There are many lessons to be learned from Class I manufacturers, and how they have handled the Final Rule - both good and bad. The UDI Forum plays host to several key Class I & II manufacturers who will be sharing their experiences. Get a headstart on compliance and discover what you can be doing right now to prepare for your own deadline, and more importantly, find out what pitfalls you can avoid!

The key message here is you cannot afford to sit on your hands and wait for the deadline. The worst thing you could do is be under the false impression that you have "plenty of time". Now is the time to act.

On the 20-22nd May 2014, project owners and senior leaders from medical device manufacturers, regulators, hospitals and key stakeholder groups will meet at the Medical Device UDIs and Traceability Summit in order to discuss real, practical solutions to many of these challenges with peers who are in the same boat. This meeting will provide a platform to benchmark against and learn from those manufacturers who have already begun this transformation, and to understand how it will affect the hospitals that make use of our devices – as well as an opportunity to meet some of the suppliers that can help with the implementation of UDIs and traceability technology.

  • Understand what impact the September 2013 FDA Final Rule on UDIs will have on your business
  • Gain clarification on the European Commission's UDI Roadmap and it's intent to maintain an international, harmonised approach in Europe to UDIs with the FDA
  • Ensure compliance with new international regulations and legislation whilst still complying with existing supply and distribution regulations, across different countries and continents
  • Discover the financial and time cost-impact UDIs are going to have on your business - how much will UDIs cost you? What do you need to do? When do you need to start?
  • Learn from other manufactuers who have already implemented part of the UDI set-up in their supply chain traceability models - what are the pitfalls to avoid?
  • Realise the additional business benefits of implementing UDIs beyond simply regulatory compliance and supply chain visibility
  • Benchmark and network with your peers and competitors who are all facing the same challenges you are





Who should attend?

Senior Vice President, Vice President, Executive Director, Director, Associate Director, Head and Manager

From departments including:
Regulatory Affairs, Supply Chain, IT, Manufacturing, Distribution, Product Security, Anti-Counterfeiting, Logistics, Quality Assurance

From companies including:
Medical Device Manufacturers
Hospitals and Medical Practices
Government and regulatory officials


Sponsors & Exhibitors
Media Partners