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.
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.