I have two questions and request discussion on each for clarity.
1. Article 14a - European databank
Paragraph 1 (d) : Data relating to clinical investigation as in Article 15 shall be stored in the european database.
* How to do this ?
* Will it be the domine of the EU rep for outside Europe manufacturers ?
* If I have the CE mark but never place the product in EU market, am I still obligated ?
* Must a OBL manufacturer also do this through his EU rep taking all necessary data and details from the OEM manufacturer who has the CE mark as said in the above point ?
2. ANNEX II - EC declaration of conformity (Full quality assurance system)
Paragraph 5.2
-
- the data stipulated in the part of the quality system related to design, such as the results of analysis, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post market clinical follow-up plan and the result of the post market clinical follow-up, if applicable, etc.,
How to make this <post market clinical follow-up plan and the result of the post market clinical follow-up> and must this be captured in the documented procedure for PMS ?
1. Article 14a - European databank
Paragraph 1 (d) : Data relating to clinical investigation as in Article 15 shall be stored in the european database.
* How to do this ?
* Will it be the domine of the EU rep for outside Europe manufacturers ?
* If I have the CE mark but never place the product in EU market, am I still obligated ?
* Must a OBL manufacturer also do this through his EU rep taking all necessary data and details from the OEM manufacturer who has the CE mark as said in the above point ?
2. ANNEX II - EC declaration of conformity (Full quality assurance system)
Paragraph 5.2
-
- the data stipulated in the part of the quality system related to design, such as the results of analysis, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post market clinical follow-up plan and the result of the post market clinical follow-up, if applicable, etc.,
How to make this <post market clinical follow-up plan and the result of the post market clinical follow-up> and must this be captured in the documented procedure for PMS ?