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MDD x PPE Directive - Statement of Non-Applicability

R

Regulatory

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#1
#1
Hello Everyone,
We manufacture X-Ray medical diagnostic equipment .Per MDD 93/42/EEC our device fall in Class IIb but we got an observation from our auditor that we have to provide any documentation/ evidence relating to applicability/non-applicability of the Personal Protective Equipment Directive 89/686/EEC (and/or the current regulation 2016/425) per MDD Article 1(6)?
PPE directive is applicable for us or not please suggest and which document or evidence we can provide to fulfill the above said requirement.
Any help or advice would be great.
 
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R

Regulatory

Involved In Discussions
#2
#2
Regulatory said:
Hello Everyone,
We manufacture X-Ray medical diagnostic equipment .Per MDD 93/42/EEC our device fall in Class IIb but we got an observation from our auditor that we have to provide any documentation/ evidence relating to applicability/non-applicability of the Personal Protective Equipment Directive 89/686/EEC (and/or the current regulation 2016/425) per MDD Article 1(6)?
PPE directive is applicable for us or not please suggest and which document or evidence we can provide to fulfill the above said requirement.
Any help or advice would be great.
Click to expand...
would be thankful if anyone share their views...
 
chris1price

chris1price

Trusted Information Resource
#3
#3
Because of the overlap of the two MDD and PPE directives, there is a need to state in your technical files, that the PPE Directive is not applicable to your medical device. I suspect this is what your NB is looking for. As long as it is obviously true, one sentence should be sufficient.
 
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