MDR Clinical Evaluation Masterclass
Series

Key to maintaining EU
market access under
more stringent
Medical Device
Regulations

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The timelines for MDR compliance are challenging. So as a leading notified body, we wanted to provide you with this detailed clinical regulatory toolkit

These five insightful webinars will help you focus on various aspects of the MDR, from looking at post-market clinical follow-up, to helping you with your medical device software and when a clinical evaluation is required. In addition, participants will gain a better overall understanding of the post-market requirements as listed under Articles 86 and 87 of the MDR.

 

Well Established Technologies: Article 61 (6) and MDCG 2020-6

A Medical Device Coordination Group (MDCG) guidance document, MDCG 2020-6, outlines the criteria for what can be considered sufficient data for legacy medical devices and Well-Established Technologies (WET). Listen to this webinar for relevant information regarding the relationship between Article 61 (6) and MDCG 2020-6, what is meant by WET devices in the MDR, what devices the MDR considers WET devices, the four criteria defining WET devices under MDCG 2020-6, what is considered sufficient data for legacy devices, and an informative question and answer session.

 

Devices Where Clinical Data Isn’t Appropriate

This webinar discusses the requirements within MDR Article 61 (10): what types of devices can fit into Article 61 (10)? On what occasions is it appropriate that clinical evaluations do not require clinical data? What data can be used to satisfy Article 61 (10)? In addition, learn about specific devices involving clinical evaluation reports and Article 7 and claims related to certain devices.

 

Claiming Equivalence Under the MDR

What does it mean to claim equivalence under the MDR? This webinar presents issues related to the general principles of claiming equivalence under the MDR. Learn about the regulatory aspects of equivalence and what is acceptable as clinical data for equivalent devices. The webinar also explains how equivalent devices are related to relevant guidance documents, how data can be supportive in a conformity assessment, and the different technical, biological, and clinical aspects of equivalence under the MDR previously known under the MDD.

 

Clinical Evaluation of Medical Software & AI Devices

This webinar examines the various topics for manufacturers to consider when managing MDR requirements for clinical evaluation of medical software and AI devices. Learn when clinical evaluations are required and how the MDCG 2020-1 guidance document relates to the process. Additionally, the webinar delves into the clinical evaluation process for a typical medical device with medical software, when clinical evaluations are appropriate, when they should be done, and the types of evaluations needed based on the device’s purpose. Learn about equivalence and when Article 61 (10) applies to specific medical devices and software.

 

MDR Post Market Clinical Followup

This webinar delves into Post Market Clinical Follow Up (PMCF) and its place in the product life cycle. The PMFC phase involves collecting clinical data in the post-market phase, during which manufacturers receive real-world feedback on the use of their devices. Manufacturers will learn about the MDR requirements, what MDCG guidance and support have to say regarding the PMCF phase, examples of PMCF plans, and types of PMCF.

 

Clinical Evaluation Under EU-MDR

After the publication of Directive 2007/47/EC in 2007, manufacturers must follow additional and revised guidelines related to the technical documentation of clinic evaluations. Understand how the requirements affect the focus of a clinical investigation and how manufacturers can understand the criteria operate in practice, specifically regarding clinical investigation scope and planning.

 

Summary of Safety and Clinical Performance

Manufacturers navigate various challenges in meeting the regulatory requirements related to Class III and implantable devices. Learn about the Summary of Safety and Clinical Performance (SSCP), a European Medical Devices Regulation 2017/745 requirement for devices to meet performance, clinical, and safety standards related to the device’s purpose. The SSCP requires manufacturers to disclose both the supportive and opposing clinical data involving specific medical devices and their relation to competing devices, reviewed and made public in a document. Understand the changes and requirements related to the SSCP and its impact on manufacturers and regulated devices.

 

MDR Clinical Investigations

Clinical investigations must have specific strategies and practices to be successful. Understand how particular requirements for clinical investigations exist under the European Medical Device Regulation 2017/745 (MDR). Conducting a clinical investigation takes ample time and requires many resources from a medical device manufacturer. Manufacturers need a clear purpose for a clinical investigation. They should understand applicable specifications and regulations and how the investigation should adhere to a quality management system and its relevant practices.

Passionate about patient safety

BSI (British Standards Institution) equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.

Our mission is to ensure patient safety whilst supporting timely market access to global medical device technology. We strive to set the global standard in thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and trusted worldwide.

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.