November 8, 2021

[FEATURED] EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due ‘By December’

The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.


In a best-case scenario 61% of today’s IVDs will be certified by the 26 May 2022 IVD Regulation deadline, and in a So far, only five standards have been published in the Official Journal of the EU in the context of the EU’s Medical Device Regulation, and four in the context of the IVD Regulation.

But more standards are due to be officially published this year, including the European versions of the international quality system standard EN ISO 13485 and of the risk management standard EN IS0 14971, standards that are the very foundation of the implementation of the MDR and IVDR but which are now going to be officially available later than the originally anticipated October deadline.

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October 14, 2021

[FEATURED] How The MDR Is Making The EU Competitively Backward

Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.


When it comes to guidances supporting the implementation of the Medical Device Regulation, major issues are being created because there is “no real possibility for industry to actively and meaningly engage in drafting EU guidances” and provide input on how to make the new system work efficiently, Elizabeth Gfoeller, corporate director, regulatory affairs at MED-EL, an EU manufacturer of globally marketed hearing loss solutions, told the first day of the meeting on 13 September.

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October 12, 2021

[FEATURED] EN ISO 13485 Linked To MDR and IVDR At Last

Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies have updated the most critical medtech standard to align it with the new EU medtech regulations.


The European standards bodies, CEN and Cenelec, have published an update to the EU medical quality management system standard to link it for the first time with the new Medical Device and IVD Regulations.

EN ISO 13485:2016+A11:2021 features new annexes demonstrating the link between specific clauses of the standard and the general safety and performance requirements (GSPR) of the MDR and IVDR.

An EN ISO standard is an international standard that has been adopted at the level of the EU. The differences are outlined in the foreword and annexes to the EU document which make the link with EU requirements.

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September 1, 2021

[Ask the Expert] Measurable Objectives and Acceptance Criteria

This session’s topic: Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

Are you looking for strategies for the verification of device safety and performance in the clinical evaluation? Are you struggling to define device safety and performance objectives? During this 45-minute Q&A session, our President Laurie Mitchell answers questions regarding how to identify meaningful safety and performance endpoints. In addition, she discusses how to demonstrate safety and performance objectives are appropriate and clinically relevant as well as what acceptance criteria is and how to define it.

Who should watch this webinar?

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. If you attended our hour-long webinar on August 25, but we did not answer your questions we encourage you to attend to get your questions answered on this topic.

Watch the recording!

Clearly Defining Measurable Safety and Performance Endpoints

All medical devices selling in Europe must have a Clinical Evaluation Report (CER). Specific and measurable safety and performance endpoints are paramount for an acceptable CER. However, many small medical device manufacturers are struggling to adequately define and subsequently document measurable safety and performance endpoints, especially in the literature review, to support an evidence-based evaluation

The newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations. 

Read more on this topic in our recent blog post, Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers.

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August 26, 2021

[FREE WEBINAR] Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

Click here to watch the recording of this webinar.

This webinar is presented from the point of view of seasoned MDR-compliant CER medical writers. Criterion Edge discusses strategies for the verification of device safety and performance in the clinical evaluation. Next, we teach you how to identify meaningful safety and performance measures for the clinical evaluation and define parameters to determine the acceptability of benefit-risk.

Key Takeaways:

Based on the state-of-the-art

  • Identify meaningful safety and performance endpoints (measures/objectives) 
  • Demonstrate that safety and performance objectives are appropriate and clinically relevant 
  • Specify acceptance criteria that are used to determine the acceptability of benefit-risk 

Who Should Watch:

Those Regulatory, Quality and Clinical leaders and regulatory writers who develop, write, review or approve Clinical Evaluation Reports for EU MDR submission. Additionally, anyone interested in learning more about MDR requirements for CERs is encouraged to watch as well. Finally, we encourage viewers from the IVD industry as well, as the content is relevant to IVDR requirements, which align closely with MDR. 

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge

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?

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