Episode description
This is the audio from RQM+ Live! #55, recorded 19 May, 2022. Listen and learn why the MDR / IVDR labeling requirements are a great opportunity to start with a blank slate and achieve global market compliance.
Medical device and IVD labeling has always been a challenge for manufacturers because updates are often required when new regulations are introduced. With the piecemeal approach that is commonly taken, the result is a product box covered in labels or inconsistent language and placement across product lines. This can be confusing and overwhelming for end users.
With the implementation of MDR and IVDR requiring significant labeling revisions, manufacturers should consider it an opportunity to start with a blank slate to both achieve global market compliance and eliminate duplicate and inconsistent information.
The reality is that labels will always need to be updated, and manufacturers need processes and systems for:
- Updating labels based on regulatory and customer requirements
- Keeping track of label changes for all products
- Assessing global impact to label changes
- Determining when to do a comprehensive label assessment
- Implementing label changes that follow best practices
- Creating new labels after an acquisition or merger
- How to respond when an error is found
Led by global regulatory experts with more than 25 years of experience, this show will discuss how to start over with labeling and create a streamlined process for future updates. By making an investment now, manufacturers will see long-term benefits, such as minimizing the impact of future updates and better streamlining for managing large-scale changes.
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Kevin Go – Project Engineer, RAC (former FDA CDRH Lead Reviewer)
- Laurie Petit, PMP – Principal Advisor
Questions:
2:35 -- What do we mean by labeling?
3:48 -- What kind of issues are you seeing, especially resulting from MDR implementation and the new labeling considerations?
9:31 -- Does labeling expand into the website content?
12:34 -- As long as your labeling is compliant, why should anyone care and consider starting from scratch?
23:04 -- Can we still supply our product with the same CMD labeling until the conformity assessment is completed or should we change our labeling?
24:18 -- Say I believe that I could save money and heartache in the long run if I overhaul my labeling... where do I start and what are some best practices?
29:06 -- Do you find that people are confused about what's really required?
38:16 -- Thinking globally, if I have to put the names and addresses of the local authorized reps for all of the countries on the label for my software device, is it compliant to put only a URL on a label that links to a website with all my ARs?
40:08 -- How far away are we from utilizing barcoding to cover common symbology translations and also legal manufacturer and economic operator addresses where there will be several to include in the UK, EU, and Switzerland importation.
41:43 -- In the EU, since we are using symbols from ISO 15223 which is harmonized under MDR, no symbol glossary is needed in the IFU. Can we supply this same IFU to the US without the symbol glossary?
45:36 -- How do you overcome labeling requirements for products that are small in size?
47:49 -- What are the types of products or scenarios where you'd say, it's time... it's time to overhaul my labeling?