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.

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February 9, 2022

[Ask the Expert] Safety and Performance (MDR)

This session’s topic: Safety and Performance Measures and Acceptance Criteria for MDR

Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do you know how to specify acceptance criteria that are used to determine the acceptability of benefit-risk?

This is a 45-minute Q&A session during which President Laurie Mitchell will answer questions like these and more. Submit your questions when you register for this forum. Please be aware that answers will be limited to 3 minutes per questions. This forum will operate on a first come first serve basis.

Who is this forum for?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Clinical Evaluation Reports for EU MDR submissions

Click here to watch the recording.

Clearly Defining Measurable Safety and Performance Endpoints

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.  

These relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently, medical device manufacturers felt the pressure to comply by May 2021.

Read more on this topic in our blog post, here.

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November 17, 2021

[Ask the Expert] Safety and Performance

This session’s topic: Safety and Performance Measures and Acceptance Criteria

Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do you know how to specify acceptance criteria that are used to determine the acceptability of benefit-risk?

During this presentation, President Laurie Mitchell and Principal Medical Writer, Dr. Sarah Chavez, answer questions on how to identify meaningful safety and performance endpoints, ensure they are appropriate and clinically relevant, how to specify acceptance criteria ranges, and more.

Who should watch the recording?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Clinical Evaluation or Performance Evaluation Reports for EU MDR or IVDR submissions

Click here to watch the recording!

Clearly Defining Measurable Safety and Performance Endpoints

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.  

These relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently, medical device manufacturers felt the pressure to comply by May 2021.

Read more on this topic in our blog post, here.

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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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