How to find applicable standards for a new product?

[GiuliaGe]

Hi everyone! I am quite new in the field of regulatory affairs and I am facing the problem of standards applicability.

The company I work for produces active medical devices in the field of hemodinamics, in particular bloood pressure monitor used in hospitals OP and ICUs.

I am looking for a reliable method for collect the right technical standard to be compliant for each product features/performance.

How do you manage this reaserch in Your company?

Thank You very much for sharing experiences.

Giulia

 

[shimonv]

Hi Giulia,
1. Best way to go about this is to look in FDA's database of approved products. In the 510k summaries you will find the list of standards they followed.
2. You can also look for user manual's of similar devices; they too include some information about standards.
3. Ask your R&D to do some research about it, including consulting with test laboratories.

Shimon

 

[Junn1992]

To add on to @shimonv, the FDA has product codes, and under each product code you will find standards applicable to the device category.

Also, you can start with EU harmonised standards list, and look through each one by one, takes around 10 - 20 minutes, but you get a good idea of standards applicable.

 

[Cybel]

To add on to @shimonv and @Junn1992 , generally the steps are:
- start from the applicable directive/regulation
- look for standards harmonized in support of that directive/regulation
The problem is that, currently, the valid applicable regulation for medical devices in Europe is the Regulation (EU) 2017/745, and for now there are only a few standards that are already harmonized: L_2021256EN.01010001.xml

My suggestion is to check the standards harmonized in support of the (old) 93/42/EEC directive and start from there, keeping in mind that you have to follow the state of the art, so the most updated standards.

 

[Sinus Tarsi]

To add on to @shimonv and @Junn1992 , generally the steps are:
- start from the applicable directive/regulation
- look for standards harmonized in support of that directive/regulation
The problem is that, currently, the valid applicable regulation for medical devices in Europe is the Regulation (EU) 2017/745, and for now there are only a few standards that are already harmonized: L_2021256EN.01010001.xml

My suggestion is to check the standards harmonized in support of the (old) 93/42/EEC directive and start from there, keeping in mind that you have to follow the state of the art, so the most updated standards.

"currently, the valid applicable regulation for medical devices in Europe is the Regulation (EU) 2017/745, and for now there are only a few standards that are already harmonized" This is correct, therefore do we add the MDR standards and keep the MDD as well?

 

[Cybel]

This is correct, therefore do we add the MDR standards and keep the MDD as well?

First use the standards that are harmonised to MDR (that are also the state of the art, I suppose - to be verified), and after the state of the art of others. Maybe there are harmonised to MDD, maybe not.

 

[Ronen E]

"currently, the valid applicable regulation for medical devices in Europe is the Regulation (EU) 2017/745, and for now there are only a few standards that are already harmonized" This is correct, therefore do we add the MDR standards and keep the MDD as well?

Look at harmonization mandate M/575 - it will give a very good idea which standards will be harmonized under MDR in the foreseeable future.