MDR and IVDR, the whitepaper on technical challenges and opportunities

UDI: what is needed to know to be compliant

Are you dealing with the challenges and new rules concerning the Medical Devices Directive? Download the whitepaper where you will find many information about the EU MDR and IVDR regulations introduced, to understand the compliance requirements.

MDR 2017/745 and IVDR 2017/746: the main challenges

Classifications and deadlines 

 UDI code: standards and rules of application

UDI printing: how, where, when and exceptions

How to connect to EUDAMED

WHITEPAPER TOPICS

What are the changes introduced with the MDR regulation and how to adapt to the legislation

To comply with the newly introduced EU MDR and IVDR regulations, medical device manufacturers are addressing multiple issues regarding regulations, technical implementation aspects, but also data and information management with EUDAMED. The complexity of these requirements, which vary accordingly to the treated products and the Countries, further complicates this task.

Therefore, companies that deal with the packaging of Medical Devices are called to quickly identify solutions that not only allow them to be compliant in the present but that are also ready for any future evolution of the regulations. What are the key points of the regulation, and what are the technical considerations to be evaluated in order to choose the best technology?

The whitepaper provides an overview of the current situation by analyzing the new requirements related to the marking and traceability of medical devices according to the UDI system and helps manufacturers to identify the success factors for a thoughtful choice of the project to be implemented.

FEATURES AND COMPLIANCE

A pharmaceutical industry specific solution

Do you want to learn more about the UDI main challenges and the solutions to be implemented? Download this whitepaper where we address topics such as:

  • UDI code: Definition, scenario and why we are talking about it
  • Do you know to which class your Medical Devices belong to? Class Definition and Coding Deadlines in the Markets
  • UDI Carrier: where to apply it? Challenge and technologies for a correct marking
  • Connection to EUDAMED. Methods, technical aspects, and deadlines

    Discover our portfolio of UDI solutions