Seeking Guidance on Identifying Standards

Hello forum members,

I am currently studying Medical Devices Regulatory Affairs and find myself facing challenges, particularly in understanding the standards and methods associated with the new General Safety and Performance Requirements (GSPRs). While I'm familiar with the list of harmonized standards, I'm struggling to locate relevant standards that may not be harmonized yet.

Could anyone kindly share insights or tips on how to identify standards for medical devices regulatory compliance when they are not yet harmonized? Your expertise would be greatly appreciated.

Thank you!

Hi @Mkane when you are trying to identify standards, that may not be harmonised, following are some important aspects to consider:

1. Only look for relevant and applicable standards. There are many standards out there, but not each of them will add value to your compliance process, so its important to evaluate relevance and applicability before putting in efforts for compliance.

2. Refer to the various website of standard organisations to find standards apart from the harmonised one. You can go to ISO site - ISO - International Organization for Standardization, ANSI American National Standards Institute - ANSI Home, and Homepage

3. Search for standards on these sites, using the right keywords, you can identify various standards which may be useful.

4. Often a standard may not be harmonised, may not be required to be mandatorily adhered to, but can act as a great reference to provide additional clarity for compliance with GSPRs requirements or the requirements of the harmonised standard.

Hope this helps.
Best,
Parul Chansoria

For the next batch you can expect to be harmonized for the EU MDR by May 2024 see:

• Register of Commission Documents
• Register of Commission Documents

In addition to Parul's advice:
You can get a list of ISO standards by Technical Committee and the standards under their scope (Just click on the "Published Standards" number). For example ISO - Technical Committees.

• ISO/TC 194 Biological and clinical evaluation of medical devices
• ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
• ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• ISO/TC 198 Sterilization of health care products
• ISO/TC 209 Cleanrooms and associated controlled environments

Or the IEC (Go to the Projects/Publications tab, and then the Publications subtab) at Technical committees and subcommittees

• SC 62A Common aspects of medical equipment, software, and system
• SC 62D Particular medical equipment, software, and system
• SC 62B Medical imaging equipment, software, and systems
• SC 62C Equipment for radiotherapy, nuclear medicine and radiation dosimetry

In lieu of knowing your keywords, just read through each of those lists, and click through to the previews if the title tickles your interest given your product.

ps. had to unlink due to a link limit (a bit odd, but not essential to the purposes of this post).

Search for standards related to the performance of your product. There are many and depending on which actor is asking they may expect conformance or justification of non-harmonized standards. MDR is behind on their list right now but notified bodies will/may ask for justification in your submission.

For the FDA reference predicate device clearances for products in your device category. They will list the relevant standards FDA will also expect from your submissions at a minimum.

Parul Chansoria said:

Hi @Mkane when you are trying to identify standards, that may not be harmonised, following are some important aspects to consider:

1. Only look for relevant and applicable standards. There are many standards out there, but not each of them will add value to your compliance process, so its important to evaluate relevance and applicability before putting in efforts for compliance.

2. Refer to the various website of standard organisations to find standards apart from the harmonised one. You can go to ISO site - ISO - International Organization for Standardization, ANSI American National Standards Institute - ANSI Home, and Homepage

3. Search for standards on these sites, using the right keywords, you can identify various standards which may be useful.

4. Often a standard may not be harmonised, may not be required to be mandatorily adhered to, but can act as a great reference to provide additional clarity for compliance with GSPRs requirements or the requirements of the harmonised standard.

Hope this helps.
Best,
Parul Chansoria

Click to expand...

I'd just like to expand slightly on point 4 here - strongly agree that application of non-harmonised (and similar in other territoried) standards to your product supports GSPR requirements and achieving state of the art. The most recent NB submission I made came back asking why we had not applied some relevant CLSI standards (which are in no way harmonised), so it's not only harmonised standards you should consider for your product.