Hi Everyone,
Im getting conflicting signals on the transition time required/allowed for the implementation of the MDR. Talking to my notified body at my last audit, they strongly implied that we would have to implement the MDR by May 26, 2020 as defined in Article 123 of the code. But talking to my EC Rep, they were telling me that that is bullshit, and that our current MDD certificate is in force until it expires, which in my case is 2024.
Paragraph 2, of Article 120 of the MDR (on transitions) states: "Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024. "
Paragraph 3 states: " However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."
My question is, am I missing anything here? Is it possible that my certificate remains valid but I am require to conform to the MDR in all aspects, or just the ones in paragraph 3? Or does the certificate mean that it is valid, and my quality system is covered until it expires?
Im getting conflicting signals on the transition time required/allowed for the implementation of the MDR. Talking to my notified body at my last audit, they strongly implied that we would have to implement the MDR by May 26, 2020 as defined in Article 123 of the code. But talking to my EC Rep, they were telling me that that is bullshit, and that our current MDD certificate is in force until it expires, which in my case is 2024.
Paragraph 2, of Article 120 of the MDR (on transitions) states: "Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024. "
Paragraph 3 states: " However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."
My question is, am I missing anything here? Is it possible that my certificate remains valid but I am require to conform to the MDR in all aspects, or just the ones in paragraph 3? Or does the certificate mean that it is valid, and my quality system is covered until it expires?
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