April 17, 2022

[FEATURED] European Commission Adds To Advice On High Risk Device Safety And Performance Requirements

The European Commission’s MDCG has issued revised guidance and advice on safety and clinical performance data required for implantable and class III devices under the MDR.

Do you like it?0
March 1, 2022

[FEATURED] Pharma, Device Groups Oppose FDA’s Planned Drug to Device Transition

Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to devices, in implementing a recent court decision.

Do you like it?0
February 25, 2022

[FEATURED] Notified Body Shortage Remains Pressing as Industry Prepares for Staggered IVDR Rollout

Three months have passed since the European Commission warned about a “grave shortage of notified body capacity,” but the situation is largely unchanged.

Do you like it?0
February 15, 2022

[FEATURED] Commission Publishes Draft Implementing Regulation For Insufficiently Regulated Products

The European Commission has published the schedule of meetings of its Medical Device Coordination Group for 2022. Launching the Eudamed database is among its priorities.

The EU’s Eudamed working group is to meet four times in 2022 in a bid to make progress on the urgently needed upgraded Eudamed medical device database, one of the cornerstones of the new Medical Device and IVD Regulations.

Do you like it?0
February 8, 2022

[FEATURED] Commission Publishes Draft Implementing Regulation For Insufficiently Regulated Products

At last, common specifications for different groups of products that do not have an intended medical purpose but are covered in the scope of the EU’s Medical Device Regulation, are on the way.

Many devices and substances used for the purpose of aesthetic enhancement have been unregulated, or only partially regulated in the EU and not in all member states.

Do you like it?0

[Free Webinar] Ask the Expert: Clinical Evaluation Report Critical Concepts

Join us on Wednesday October 10th, 2022 at 11AM PST / 2PM EST, as President Laurie Mitchell answers your questions regarding safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. Learn best practices and writing strategies to support solid planning during your own writing process.

Spots are limited – click to register for this free webinar.

Check out our Events Calendar for our upcoming webinars.

Named the #1 Regulatory Services Company 2022 by Life Sciences Review

X