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

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Nam et dui sit amet dolor blandit aliquet. Etiam tristique a mauris ac posuere. Vestibulum rutrum dolor auctor, posuere ante et, rutrum nulla. Nunc vehicula maximus enim, in mattis nulla bibendum ac. Sed malesuada neque eu arcu dictum, vitae iaculis sem vestibulum. Morbi nec malesuada justo. Quisque mattis, magna ac efficitur cursus, ante nisl luctus diam, nec eleifend tortor dolor vitae eros. Mauris feugiat consectetur interdum. Proin dapibus congue ex, cursus posuere libero imperdiet ornare. Quisque cursus felis justo, nec euismod leo sodales in. Duis ut suscipit augue.

Curabitur sodales eget nulla in vestibulum. In efficitur vulputate tincidunt. Ut et erat sagittis, pharetra dolor sed, semper ipsum. Vestibulum ornare scelerisque arcu. Fusce placerat mollis efficitur. Praesent in nulla id lacus posuere mattis. Integer rutrum ullamcorper dignissim. Sed congue, augue sit amet imperdiet blandit, risus erat dignissim arcu, quis congue quam justo sed leo. Orci varius natoque penatibus et magnis dis parturient montes, nascetur ridiculus mus. Integer ac velit lorem. Suspendisse eget tempus augue, eget efficitur sapien. Suspendisse eu ex sapien. Nullam sed lorem porttitor, efficitur enim et, gravida neque. Maecenas vel iaculis leo. Curabitur congue tortor non erat congue pretium.

Etiam quis placerat quam. Sed tempor sit amet ex non volutpat. Nam scelerisque turpis at dolor vestibulum dignissim. Sed sed risus sagittis ligula placerat malesuada. Suspendisse ut sapien condimentum, pharetra erat non, varius libero. Nunc eget pellentesque magna. Pellentesque non eros enim. Suspendisse scelerisque, odio id semper ultrices, orci augue sodales ligula, eu scelerisque turpis nibh vel nulla. Morbi vel nisi at sapien varius sagittis id consequat odio.

Fusce vel faucibus ipsum, sit amet elementum nisi. Nulla varius nulla purus, eu mollis mauris congue in. Integer placerat non justo vel convallis. Fusce egestas blandit nunc pellentesque consequat. Sed lobortis mollis magna ac aliquam. Integer id lectus mi. Nulla vitae posuere odio. Orci varius natoque penatibus et magnis dis parturient montes, nascetur ridiculus mus. Vestibulum a dignissim sem. Maecenas feugiat vulputate justo nec euismod. Aliquam mollis condimentum turpis at elementum. Suspendisse congue sem id dolor rhoncus dignissim. Vivamus vel hendre