April 28, 2022

[Ask the Expert] Common Notified Body Review Findings

tips to avoid common notified body review findings

This session’s topic: Tips For How to Avoid Common Notified Body Review Findings

Criterion Edge is often approached by clients with MDR Clinical Evaluation Reports (CERs) that require extensive revisions based upon Notified Body review and feedback.  Addressing NB feedback costs your team time and effort and may threaten critical submission deadlines. However many of these issues might have been avoidable with thorough pre-planning, proper project scoping and asking the right questions from the beginning.  In this “Ask the Expert” question-and-answer session, we will show you some of the most common issues our writing team encounters with clients who face these revisions and discuss how they can be avoided. Presented from the perspective of experienced medical writers, we hope to provide examples of how solid planning during your own writing process can help you avoid the most common missteps in your own CER or PER.

During this 45-minute session, come prepared with your questions for our experts to answer regarding your notified body review findings. Please submit them ahead of time while registering so we have ample time to answer them thoughtfully. Also, please be aware that answers will be limited to 3 minutes per question.

This forum will answer questions on a first come first serve basis, so please submit all your questions when you register for this event.

Who is this forum for?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.

Click here to watch the recording of this session.

“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits

Notified Bodies (NBs) across Europe along with global manufacturers are facing resource constraints. The cause? Additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, the European notified body association, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines.

The primary concern cited is the likely device shortage for patients. More complex and longer certification processes required under MDR/IVDR are influencing this shortage. In conjunction, the demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs). With only 25 NBs for MDR and 6 for IVDR, the demand outweighs supply. Compared with 51 NBs designated for MDD and 21 under the AIMDD/IVDD Directives, manufacturers are in a tough situation now compared to years prior.

Team-NB identified the following four primary contributing factors, summarized in our recent blog post here.

Categories:
Do you like it?0
January 11, 2022

[FEATURED] Where And How eIFU Rules Will Apply Under The EU’s Medical Device Regulation

Provision of electronic instructions for use for devices is now a well-established practice. But there are conditions. A new Implementing Regulation explains how these apply under the Medical Device Regulation.


European Commissioner for Health and Food Safety Stella Kyriakides is calling on EU member states to “equip your authorities with the resources they need” to deal with the 11 pending applications for notified body designation under the IVD Regulation.

The possibility of providing instructions for use in electronic form instead of paper should be limited to certain medical devices and accessories intended to be used under specific conditions, the document states.

“For reasons of safety and efficiency,” it notes, “users should always have the possibility to obtain those instructions for use in paper form upon request.” The document also lays out rules for eIFU information made available on manufacturers’ websites.

Do you like it?0