Accredited laboratory or not under MDD 93/42/EEC

[Belen Sanchez]

Today in my company we have dissussed about this question that I have never raised myself, the question is if our producs (electronical medical devices class I and IIa under MDD 93/42/EEC) needs that the tests according to EN 60601-1 and EN 60601-1-1 must be performed by an external laboratory accredited or not.

I always have used accredited laboratories to performing these standards and justify the safety and EMC of the medical devices.

But, my new company, if it's a class I, it 's used a not accredited external lab, and if it's a class IIa, it's used an accredited external lab.
And a third option, today has been raised: don't use an external lab for class I products, for example points about labelling, user manual...

And I didn't know reply this question, I know that manufactures use accredited external lab beacuse it's easier to justify the conformity of the products, but how can I justify safety standard without an external laboratory? Thanks a lot for your help

 

[yodon]

I've worked with companies that do their own testing so having a lab is not absolutely required. Such data would likely be highly scrutinized by any reviewer. The benefit of using an accredited lab is that they have already jumped through all the hoops to ensure the data is acceptable.

If you want a safety mark, though, you need to go with an accredited lab. I think you may be able to submit your data (if you do the testing) for review by an accredited lab and if all is in order, they may allow you to apply their mark. I've worked with one test lab that submits their data to UL for enabling the mark.

 

[Benjamin Weber]

Under MDD (and the coming MDR) there is no requirement for accredited testing. This does also not depend on the class of the device. You are allowed to perform the safety tests at your company. But: The auditors of the notified bodies or the competent authority in your country will look very closely at the results and on the way you performed the tests. The level of scrutiny will increase with class of the device.

What does this mean for you, when you perform the tests in your own company? You will most likely have to comply with some or a lot of the requirements of ISO 1705, showing that you are competent to perform the tests. This starts with having the correct measurement equipment, performing continuous calibration with metrological traceability to international standards, comparing yourself with other test labs, performing proficiency testing, nowing the details of the test specifications...

There is a lot more to it than just doing the tests correct! And the biggest problem may be - The required impartiality of an accredited test lab! That is what small and middle sized enterprises usually cannot provide, in order to perfom safety tests for maybe not more than five different products. Bigger companys have their own inhouse test labs, but those are usually also accredited to ISO 17025.

So when you let an accredited test lab perform the safety tests, your notified body and the competent authorities will have much more confidence in the test results and you will have less discussions.

Sometimes it is possible to perform test on your own, give the results to a test lab, and they give you a test report under their signature. But usually you have to show, that you are competent for the tests in advance and the test lab may require so called witness testing, i.e. a representative of the test lab visits you at your comapny and witnesses some or maybe all of the tests. But as far as I know this is an exception, for example for bigger companies who want to have an CB certificate.

 

[Tidge]

There is a lot more to it than just doing the tests correct! And the biggest problem may be - The required impartiality of an accredited test lab!

I occasionally remind folks: One element of paying for testing at an accredited 3rd party agency is that by paying for such testing part of the payment is to ensure that the 3rd party is holding their other customers (some of whom are your competitors) to the same standard they are holding you to. This advice doesn't always ease the sting cause by the bill (and sometimes the test results)!

 

[MDRMust]

Question here:

When you choose an accredited laboratory for the Safety & EMC testing under MDR regulation;

1- Are you required to provide the testing operating procedure?
2- Are you required to just provide the reference standard and the regulation reference ( MDR regulation here)???

 

[Benjamin Weber]

Question here:

When you choose an accredited laboratory for the Safety & EMC testing under MDR regulation;

1- Are you required to provide the testing operating procedure?
2- Are you required to just provide the reference standard and the regulation reference ( MDR regulation here)???

When you decide to test your device in an accredited testing laboratory you just have to know which standard to be tested. An accredited testing lab has the corresponding test procedures and ISO 17025 also requires the test lab to assure that the client chooses the correct standard. If just ask for safety testing, they will ask you in detail which standard and if applicable which edition of the standard, if there are multiple active editions.

 

[Pads38]

For EMC testing you will have to work with the test house to create the 'Test Plan'. This has to be agreed and put into place before any testing takes place.
This is because, during EMC testing, you have to operate the device in a 'worst case' scenario and be able to monitor it's operation. You also need to define Essential Performance, that is the performance that must be maintained during the immunity tests.
You will also need to define all connecting cables, operating modes and any special use environments.

 

[Benjamin Weber]

For EMC testing you will have to work with the test house to create the 'Test Plan'. This has to be agreed and put into place before any testing takes place.
This is because, during EMC testing, you have to operate the device in a 'worst case' scenario and be able to monitor it's operation. You also need to define Essential Performance, that is the performance that must be maintained during the immunity tests.
You will also need to define all connecting cables, operating modes and any special use environments.

That is right, wou have to have a test plan for EMC testing and most EMC test labs will assist you to create one.

Regarding essential performance: You don't necessarily have to define EP for EMC testing. Be careful and read the definition of EP in 60601-1! If your device does not have any EP, you don't have to define such for EMC testing. BUT: You have to define Pass/Fail criteria for immunity testing. These are functions, that you consider should not be adversely affected during immunity testing. For example you can define that the screen is allowed to go black or flicker for e few seconds (you have to say how long exactly is OK) or even that the device can turn off completely, but function shall be restored after turning on again (happens sometimes during contact discharge). But these functions need not be EP as defined in 60601-1!

Of course: If your device has EP, then this should also not be affected by immunity testing.

 

[Marcelo]

I would take care, specifically with the essential performance side. Ir device might not have essential performance (although in general most devices would), but we have been having some problems with the way test houses understand and apply the EP requirements. Basically, they don't understand the concepts very well and most do not apply the related requirements correctly. This was discussed last month in the IEC TC 62 meeting in China and the TC is going to perform some actions, including probably some guidance, to clarify how to correctly apply the requirements (they main discussion was about the failures which have to be tested, but the discussion was also applicable to EP in general too).

 

[Tidge]

This was discussed last month in the IEC TC 62 meeting in China and the TC is going to perform some actions, including probably some guidance, to clarify how to correctly apply the requirements (they main discussion was about the failures which have to be tested, but the discussion was also applicable to EP in general too).

This is very encouraging!