Preparing for MDR: Don’t Forget About Class I Reusable Devices

Preparing for MDR: Don’t Forget About Class I Reusable Devices

Medical device manufacturers are busy preparing for the about MDR and Class III device changes. As you work through your portfolio and sort your products into families, you’ll face many tough decisions. You need to be aware of some key changes to the regulations –

• Device classification changes
• New classes of medical devices, including Class Ir for reusable devices.
• Lack of extensions for Class Ir
• Grandfathering in legacy devices will be strictly prohibited.

As of May 26, 2020, every Class Ir device must have an MDR CE mark to be permitted in the market.

Learn more about the new subclass for Class Ir under MDR and the necessary steps to ensure compliance in the recent MedTech Intelligence article by Dan Fowler, WuXi AppTec’s Principal Scientist for reprocessing.

“Preparing for MDR: Don’t Forget about Class I Reusable Devices” echoes countless experts on the importance of timelines and preparation. It also highlights critical components of robust validation studies for reusable devices, five rules of testing to keep in mind, reasons studies fail, and more.

Read the Full Article




MDR & ISO 10993-1: How to Navigate Preclinical Device Testing

MDR & ISO 10993-1: How to Navigate Preclinical Device Testing

Medical Design Briefs online recently featured an article written by Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi AppTec, expert in re-writing ISO 10993-18 as part of TC 194 / Working Group 14.

“Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1” shares important information that medical device OEM’s need to know about the impending regulatory updates and submission deadlines.

In this article you will learn:

  • The new ISO 10993-1 and MDR testing requirements
  • How to perform a gap analysis
  • The proper sequence of preclinical device testing
  • The importance of chemical characterization and when to do it
  • Questions to ask when vetting a CRO

Read the Article Here

If you have questions or want to discuss your MDR & ISO 10993-1 journey, contact us! Read more about ISO 10993-1 and MDR regulations:

How to Plan for EU MDR So You Can Sleep at Night

Preclinical medical device testing under ISO 10993-1 and the MDR

Radiation sterilization: verifying dose survivors

Radiation sterilization: verifying dose survivors

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