March 16, 2022

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

Author: Stacie Beecham

Resource constraints facing global manufacturers are also being felt by Notified Bodies (NBs) across Europe, due to the 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 that Europe faces a likely device shortage for patients due to the more complex and longer certification processes required under MDR/IVDR. 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, as compared with 51 NBs designated for MDD, and 21 under the AIMDD/IVDD Directives.

Do you like it?0
February 25, 2022

Expert Opinion Panels and New Guidance Documents Are Part of the Changing Landscape of MDR 2017/745

Author: Suzanne Broussard, PhD  | February 25, 2022

The European Union (EU) saw 2021 bring important milestones and changes to the implementation of Medical Device Regulation (MDR) 2017/745. Key highlights included compliance dates, expert opinion panels, newly published guidance and standards. 

MDD Grace Period Extension

The original deadline of 26 May 2021 for MDR 2017/745 compliance has come and gone, and many medical device manufacturers with devices granted a CE mark under MDD are taking advantage of the 26 May 2024 grace period to become fully complaint with MDR. As of September 2021, the EU notified bodies had granted only 502 conformity assessment certificates, thus, it is anticipated there will be an extreme bottleneck in 2023 and especially in 2024 due to limited notified body availability as manufacturers scramble to meet the May 2024 deadline.

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
February 1, 2022

[FEATURED] Updated Version Of EN ISO 13485 Now Officially Harmonized Under MDR Along With Other Standards

The New Year has seen the official publication of a series of long-awaited new medtech standards, including some that are critical to large swathes of the medical device industry.

It’s official! The updated version of the EU quality system standard EN ISO 13485, which is relevant for the whole of the medtech industry, is now formally recognized as a “harmonized” standard in the context of the EU’s Medical Device Regulation.

Do you like it?0
January 20, 2022

[FREE WEBINAR] Post-Market Literature Surveillance: Systematic Literature Review and Case Study

Click here to watch the recording of this webinar.

Joining Criterion Edge’s President Laurie Mitchell, is guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions​. In this webinar, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance, and share best tips on a robust systematic literature review process. Following this, our guest speaker shares an informative case study illustrating more.

Key Takeaways:

  • How leveraging published data can help meet regulatory expectations and inform internal decision-making​
  • Steps for conducting a methodologically-sound SLR​
  • How data obtained through SLR can empower the successful execution of post-market surveillance activities, drive efficiencies and support regulatory compliance. 

Who Should Watch:

Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge

Queenita Fernandes, Medical Safety Manager | Medtronic

Sign up for future webinars or view our events calendar.

Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

Do you like it?0

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