Webinar: Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers

When: Tuesday, June 25, 2024  

Time: 11:00 a.m. – 12:00 p.m. EDT 

About the Event: Join BSI & Leo Eisner for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Leo the “IEC 60601-1 Guy” will present the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.

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Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

𝗕𝗥𝗘𝗔𝗞𝗜𝗡𝗚 𝗡𝗘𝗪𝗦 𝗜𝗠𝗗𝗥𝗙 𝗡𝟰𝟳 & 𝗡𝟱𝟮 recently updated to 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟮 – 𝗪𝗵𝗮𝘁’𝘀 𝘁𝗵𝗲 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽 𝘁𝗼 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝟰𝘁𝗵 𝗲𝗱

IMDRF N47 & N52 both have been updated which will support Regulatory Submissions and Compliance Testing for the future of the IEC 60601 series including IEC 60601-1, 4^th edition. 𝗜𝗠𝗗𝗥𝗙 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 two Final documents on 𝟮𝟲 𝗔𝗽𝗿𝗶𝗹 𝟮𝟬𝟮𝟰, both to Version 2:
N47 Essential Principles of Safety and Performance of Medical Devices & IVD Medical Devices, and
N52 Principles of Labeling for Medical Devices and IVD Medical Devices

The 𝗽𝘂𝗿𝗽𝗼𝘀𝗲 𝗼𝗳 𝗡𝟰𝟳 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 is to provide harmonized Essential Principles that should be fulfilled in the design & manufacturing of medical devices and in vitro diagnostic (IVD) medical devices to ensure that they are safe and perform as intended.  The worldwide adoption of a common set of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to, among others, manufacturers, users, patients/consumers, and to Regulatory Authorities.  Reducing differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.

While 𝗡𝟱𝟮 𝗹𝗲𝘃𝗲𝗿𝗮𝗴𝗲𝘀 𝗼𝗻 𝗡𝟰𝟳 𝗮𝘀 𝗶𝘁’𝘀 𝗽𝘂𝗿𝗽𝗼𝘀𝗲 states this guidance is to provide globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support N47.  Specifically, this document provides guidance on the content of the label, instructions for use, and information intended for the patient in order to support the safe and effective use of medical devices and IVD medical devices by their intended users.

With the 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝟰𝘁𝗵 𝗲𝗱𝗶𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗷𝗲𝗰𝘁 underway 𝗼𝗻𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗗𝗲𝘀𝗶𝗴𝗻 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 – 𝗚𝗼𝗮𝗹 𝟲 of the 𝗔𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗲 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻:

“Establish a policy relating requirements of the IEC 60601 series to the IMDRF essential principles and labelling principles.”
𝗚𝗼𝗮𝗹 𝟲 𝗶𝘀 𝗱𝗶𝗿𝗲𝗰𝘁𝗹𝘆 𝗿𝗲𝗹𝗮𝘁𝗲𝗱 𝘁𝗼 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀 𝗡𝟰𝟳 𝗮𝗻𝗱 𝗡𝟱𝟮 𝘄𝗵𝗶𝗰𝗵 𝘄𝗲𝗿𝗲 𝗿𝗲𝗰𝗲𝗻𝘁𝗹𝘆 𝘂𝗽𝗱𝗮𝘁𝗲𝗱 𝘁𝗼 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟮.

The Architecture Spec states:

“It is the 𝗽𝗼𝗹𝗶𝗰𝘆 𝗼𝗳 𝗜𝗘𝗖/𝗧𝗖 𝟲𝟮 𝘁𝗼 𝗶𝗻𝗰𝗹𝘂𝗱𝗲 𝗮𝗻 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝘃𝗲 𝗮𝗻𝗻𝗲𝘅 𝗺𝗮𝗽𝗽𝗶𝗻𝗴 the 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽 𝘁𝗼 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙 𝗘𝗦𝗦𝗘𝗡𝗧𝗜𝗔𝗟 𝗣𝗥𝗜𝗡𝗖𝗜𝗣𝗟𝗘𝗦 𝗮𝗻𝗱 𝗟𝗔𝗕𝗘𝗟𝗟𝗜𝗡𝗚 𝗣𝗥𝗜𝗡𝗖𝗜𝗣𝗟𝗘𝗦 in 𝗲𝗮𝗰𝗵 𝗼𝗳 𝘁𝗵𝗲 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗦𝗘𝗥𝗜𝗘𝗦.”
This is a goal of IEC/TC 62.  For the IEC 60601-1, 4^th edition project all Working Groups (WG’s) are tasked to do this work in their WG’s.  There are 12 WG’s split up by hazards. In the future all standards that are developed by IEC/TC 62 should also follow this goal.
Another part of Goal 6 from the Architecture Spec states:
“The 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗶𝗻 𝗺𝗮𝗻𝘆 𝗼𝗳 𝘁𝗵𝗲 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗦𝗘𝗥𝗜𝗘𝗦 are 𝗶𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝘁𝗼 𝗳𝘂𝗹𝗳𝗶𝗹 𝘀𝗼𝗺𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗽𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 set out 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀. To facilitate the usage of the documents in the IEC 60601 SERIES for conformity assessment purposes by the AUTHORITIES HAVING JURISDICTION, it is important to 𝗰𝗹𝗲𝗮𝗿𝗹𝘆 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗲 𝘄𝗵𝗶𝗰𝗵 𝗜𝗠𝗗𝗥𝗙 𝗽𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗮𝗿𝗲 𝗰𝗼𝘃𝗲𝗿𝗲𝗱 𝗯𝘆 𝘄𝗵𝗶𝗰𝗵 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗶𝗻 𝗮 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗦𝗘𝗥𝗜𝗘𝗦.”
This 𝗚𝗼𝗮𝗹 𝟲 𝘀𝘂𝗽𝗽𝗼𝗿𝘁𝘀 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙’𝘀 𝗰𝗼𝗻𝗰𝗲𝗽𝘁 𝗼𝗳 𝗲𝗹𝗶𝗺𝗶𝗻𝗮𝘁𝗶𝗻𝗴 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝗰𝗲𝘀 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗷𝘂𝗿𝗶𝘀𝗱𝗶𝗰𝘁𝗶𝗼𝗻𝘀 which 𝗱𝗲𝗰𝗿𝗲𝗮𝘀𝗲𝘀 𝘁𝗵𝗲 𝗰𝗼𝘀𝘁 𝗼𝗳 𝗴𝗮𝗶𝗻𝗶𝗻𝗴 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 from the various AUTHORITIES HAVING JURISDICTION (AHJ) and allows 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝗲𝗮𝗿𝗹𝗶𝗲𝗿 𝗮𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝗻𝗲𝘄 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀 𝗮𝗻𝗱 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀.  This is a positive impact on patients and also makes for an easier process for the manufacturers and for the AHJ’s, as well.

When IEC TC 62/SC 62A/WG 39 met in Arlington, VA on 1- 2 May 2024 this was brought up during the meeting, as this is an important issue that needs to be addressed during the IEC 60601-1, 4^th edition project. One aspect WG 39 is dealing with is “Information to be supplied by the manufacturer” (i.e. Labeling).  This is the IEC 60601-1, 4^th edition WG that I am a co-convener of. There are lots of changes happening in the standards and regulatory world around labeling and we are working hard to keep informed on all these changes that will impact this project. 𝗦𝘁𝗮𝘆 𝘁𝘂𝗻𝗲𝗱 𝗳𝗼𝗿 𝗺𝗼𝗿𝗲 𝘂𝗽𝗱𝗮𝘁𝗲𝘀

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

Last week, 29 Apr – 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

The focus of this meeting was “level setting” all the parties on the development of requirements for the 4th edition of IEC 60601-1, which sets safety requirements for medical electrical equipment (also known as active medical devices). Twelve working groups (WGs) gathered to strategize their efforts, guided by the Design Specification for the 4th edition and the Architecture Specification.  The first day was set with training to help all parties get an understanding of project requirements and ask questions based on the Design Specification and the Architecture Specification. The next 3 days focused on the 12 WGs working on their strategies for the start of the project and the plans to move forward. The last day was a wrap-up and getting feedback on how to improve the process with lots of great discussion from the week. 

An Advisory Group (AG 50) is used to collaborate with all 12 WG co-convenors and secretaries, and IEC SC 62A officers ensuring the overall success of the project.

As a co-convenor for WG39, which addresses User Interfaces (Including information provided by the manufacturer, Alarm Systems and Usability Engineering Process), I am honored to be part of this excursion in the development of this standard for the support of the healthcare industry for the next edition. Alongside my co-convener, Martin Stangenberg, we led discussions and consensus-building within our WG. Our WG is comprised of amazing experts.  We had over 30 experts in the room including regulators from 5 countries; test houses; usability, labeling, alarm systems, and robotics experts. We had over half of our experts from the whole WG in attendance at the meeting. Our responsibilities include coordinating with other experts to develop basic safety and essential performance requirements related to User Interface Aspects Hazards for our part of the standard. Each WG is working on a different set of hazards as described in the post “IEC 60601-1, 4th ed. — Where do we stand?“.

As an expert on WG37, I also spent part of the week with WG 37 developing requirements related to general issues concerning underlying concepts including basic safety & essential performance, single fault safety, type testing.  Correlation with processes relevant for IEC 60601-1 defined by other process standards (e.g., risk management) for IEC 60601-1, 4^th ed.

It was great to meet all the new people and see them get involved for the first time in the standardization process as well as work with familiar faces I have worked with for many years. It is a well-rounded group of individuals, supporting this next edition, with many different perspectives but with the mindset to provide the patient with a safe product.

I extend my appreciation to all who have made this happen — the officers, the design specification and architecture specification teams (a long road to get here), my mentors, and all the national committee experts for coming together in this massive effort. Now the real work of the experts in the WGs begins….

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.