ISO 13485:2016 Applicable regulatory requirements

[Alyana]

Hi Cove,

I need a clarification regarding 'applicable regulatory requirement' as mentioned in the standard. What does it mean? Do we need to mention precisely the name of each regulatory for the affected clauses?

If one medical device is being marketed to many countries that all have own regulatory requirement, do we need to mention all?

Thanks all in advance.

Regards,
Alyana

 

[somashekar]

Hi Cove,

I need a clarification regarding 'applicable regulatory requirement' as mentioned in the standard. What does it mean? Do we need to mention precisely the name of each regulatory for the affected clauses?

If one medical device is being marketed to many countries that all have own regulatory requirement, do we need to mention all?

Thanks all in advance.

Regards,
Alyana

One of the main input in establishing a QMS for Medical devices is the Regulatory. These requirements must be understood well with proper training or such other means and the requirements must be integrated within the established QMS. Since various regions have their own specific requirements, and the requirements differ depends upon the class of the device, and the classification is also not the same across the regions, you need to apply yourself well (perhaps even with some expert consultancy) to determine how each of the applicable regulatory requirements are going to be met.
Offcourse, as these are overlapping, meeting one regulatory requirement may also fully or partially meet other regulatory requirements.
Its a good practice to list the product, its classification under the various regulations to which its applicable based on your market penitration within your quality manual.
Its not required to address regulatory clausewise in your QMS documentation, unless it really is helpful to you.

 

[regork]

Hi Alyana,
For the scope of your company, product, service, role, etc. the applicable regulatory requirement is a requirement specified by an authority mandated by a legislative body.

In the company quality manual, define the high level legislative requirements that apply to your company and the role you company has in a medical device (MD) life cycle or MD supply chain. For example, the FDA has its 21 CFR 820 Quality System Regulation (QSR) that is a high level QMS requirement.

Once you have the list of countries, develop a matrix of requirements for your quality system and implement your procedures necessary to fulfill the matrixed requirements. I recommend going one step further and include a reference table to each of the clauses, sub requirements that must be met in each procedure.

As most of the legislative bodies have MD QMS requirements that are somewhat harmonized, get better w/ MDSAP, you may decide to maintain one setup of procedures for all your MD products / services. Or - you can define in your product development process, the specific methodologies, processes, and instructions you will follow during product development. Same as for the transfer into product and service, your design transfer plan and medical device file can define the specifics of each MD and process to follow.

Next at the product development level, define the applicable regulatory requirements during each project. I use a regulatory strategy process and template to help the team define each country and its required regulatory requirements.

The final step is to ensure that you have evidence (a record) that the predetermined regulatory requirements for each of your MDs have actually been realized during the product fulfillment lifecycle.

Best,
Regork.