Implementation 2013/59/Euratom

[Kuldeep Singh]

Hello All,

I am not able to find any thread on 2013/59/Euratom , The reference to Directive 2013/59/Euratom (safety standards for protection against ionizing radiation) in GSPR 16.4(a) of EU MDR 2017/745. so i am starting this thread.

The question is , how to show compliance with this directive. Of course this directive is applicable to us, as we are manufacture of X-ray medical devices. There are 109 articles , should we create a table as we do in case of GSPR (Table in which left side contains the Article 1 to 109 requirement and column on right side contains our justification or methods to show compliance against it).

Thanks in advance , your help will be appreciated.

 

[dgrainger]

Hi,
2013/59/Euratom regulates use of ionising radiations and isn't a product regulation. There are some equipment requirements in Articles 60&78 but these are more about use than placing on the market.

 

[Kuldeep Singh]

Thank you dgrainger for your reply.

So what i understand is , should we show only compliance to Article 60 & Article 78??

Most of the article seems to applicable on Radioactive materials.

 

[dgrainger]

You need to comply with these if you carry out work with ionising radiations in the EU.

The equipment requirements are mostly about what can be used rather than how it is made.

These are also directives so you need to check member state implementation.

In the UK (The Ionising Radiations Regulations 2017), the duties to comply fall on employers to select/use equipment. The exception is reg 32:

Duties of manufacturers etc of articles for use in work with ionising radiation​

32.—(1) In the case of articles for use at work, where that work is work with ionising radiation, section 6(1) of the 1974 Act (which imposes general duties on manufacturers etc. as regards articles and substances for use at work) is modified so that any duty imposed on any person by that subsection includes a duty to ensure that any such article is so designed and constructed as to restrict so far as is reasonably practicable the extent to which employees and other persons are or are likely to be exposed to ionising radiation.​

(2) Where a person erects or installs an article for use at work, being work with ionising radiation, that person must—​

(a) undertake a critical examination of the way in which the article was erected or installed for the purpose of ensuring, in particular, that—​

(i) any safety features and warning devices operate correctly; and​

(ii) there is sufficient protection for persons from exposure to ionising radiation;​

(b) consult with the radiation protection adviser that they appointed, or that the employer engaged in work with ionising radiation appointed, with regard to the nature and extent of any critical examination and the results of that examination; and​

(c) provide the employer engaged in work with ionising radiation with adequate information about proper use, testing and maintenance of the article.​

If you meet MDD/MDR requirements then you should be ok for part 1. It's part 2 you need to comply with if you install a device.

UK regulator information: Health and Safety: Ionising Radiation

 

[Roland chung]

I would also like to know, as an X-ray system manufacturer, how to present evidence of compliance with the Directive 2013/59/Euratom?

Best regards
Roland

 

[Morne]

I am struggling with the same request. I am just going to write here, into the void, and maybe someone who is really knowledgeable about this topic will jump in.

Euratom directive is a state-level directive, implementation would be conducted by Ministries, Directorates, etc., and there is nothing much that a manufacturer could prove. IF you were a manufacturer of let's say, radiography products, INSIDE the EU, you would have to register with a national level competent body to approve your work and facilities in the field of ionising radiation emitting products. your registration with this govt. body would prove compliance to Euratom, because the body responsible for your registration/certification implements Euratom directly (as an EU member-state body).

If you are OUTSIDE the EU, it becomes impossible, as far as I can tell, to directly prove compliance. Each individual country would have its own legislation controlling and monitoring radiation emitting activities, and you would be legally required to register with them. The only way for you to definitively prove compliance to Euratom Directive would be to prove beyond doubt that national legislation in your country of operation matches Euratom 1:1. I believe this is really beyond the capabilities of a regulatory compliance person working in isolation...indeed this type of project would usually take a few years when organised by governments themselves, employing teams of lawyers and other experts.

What I explained to one of my clients, who needed to prove this compliance to Euratom was the following:
This client had already purchased and installed a device inside an EU state. As per Euratom, the device was inspected and tested by a medical physicist employed by the health institution, and passed all tests. In this case, the installed, tested device inside the EU state has proven compliance with Euratom quite definitively. While the device in a factory outside the EU, is in a grey zone.

If anyone who has dealt with this before, and did find a way to prove compliance with Euratom while working in a "3rd country", that would be very helpful information.

Could a representative from an EU member state government body responsible for radiation activities come to a 3rd country and conduct an assessment? My understanding is that they do not have the legal jurisdiction to issue anything outside the EU itself...and that even should you "pass" their assessment, they couldn't legally issue you permission/certification...perhaps I am wrong here?

 

[Louisa Ritchlin]

Hello All,

I am not able to find any thread on 2013/59/Euratom , The reference to Directive 2013/59/Euratom (safety standards for protection against ionizing radiation) in GSPR 16.4(a) of EU MDR 2017/745. so i am starting this thread.

The question is , how to show compliance with this directive. Of course this directive is applicable to us, as we are manufacture of X-ray medical devices. There are 109 articles , should we create a table as we do in case of GSPR (Table in which left side contains the Article 1 to 109 requirement and column on right side contains our justification or methods to show compliance against it).

Thanks in advance , your help will be appreciated.

Hello Kuldeep Singh, were you ever able to find how to show compliance with this directive? Thanks in advance!

 

[Louisa Ritchlin]

I am struggling with the same request. I am just going to write here, into the void, and maybe someone who is really knowledgeable about this topic will jump in.

Euratom directive is a state-level directive, implementation would be conducted by Ministries, Directorates, etc., and there is nothing much that a manufacturer could prove. IF you were a manufacturer of let's say, radiography products, INSIDE the EU, you would have to register with a national level competent body to approve your work and facilities in the field of ionising radiation emitting products. your registration with this govt. body would prove compliance to Euratom, because the body responsible for your registration/certification implements Euratom directly (as an EU member-state body).

If you are OUTSIDE the EU, it becomes impossible, as far as I can tell, to directly prove compliance. Each individual country would have its own legislation controlling and monitoring radiation emitting activities, and you would be legally required to register with them. The only way for you to definitively prove compliance to Euratom Directive would be to prove beyond doubt that national legislation in your country of operation matches Euratom 1:1. I believe this is really beyond the capabilities of a regulatory compliance person working in isolation...indeed this type of project would usually take a few years when organised by governments themselves, employing teams of lawyers and other experts.

What I explained to one of my clients, who needed to prove this compliance to Euratom was the following:
This client had already purchased and installed a device inside an EU state. As per Euratom, the device was inspected and tested by a medical physicist employed by the health institution, and passed all tests. In this case, the installed, tested device inside the EU state has proven compliance with Euratom quite definitively. While the device in a factory outside the EU, is in a grey zone.

If anyone who has dealt with this before, and did find a way to prove compliance with Euratom while working in a "3rd country", that would be very helpful information.

Could a representative from an EU member state government body responsible for radiation activities come to a 3rd country and conduct an assessment? My understanding is that they do not have the legal jurisdiction to issue anything outside the EU itself...and that even should you "pass" their assessment, they couldn't legally issue you permission/certification...perhaps I am wrong here?

Thanks for asking this again, I am looking for the same answer.....

 

[Roland chung]

With the implementation of MDR, has anyone had a successful experience at this point?