Rob Packard For a significant risk study you need approval from a competent authority, but not all countries have this role centralized. There is also ethics review board approval required for all studies. The submission format is not as formal and much easier to prepare as well. We will also be seeing some changes in the immediate future regarding clinical evaluations (revision is coming for the MEDDEV).

Malcolm Applewhite If I can comment here by asking a question of clarification. Are you saying that CE marking is needed prior to clinical trials/studies?

Armin Beck Dear Justyna:: There have been significant changes within the EU in last few years and now you need always approval from the Competent Authority and the local Ethical Committee. That can be tricky and you need to understand the regional difficulties choosing the clinical site. I have done many trials in Europe and could help further.

Best,

Armin Beck 925-212-7683

Marcus Gould Further to what Rob said the ease of obtaining a 'No Objection' for conducting a clinical investigation here in Europe depends upon the competent authority. I have dealt with clinical investigations to the MHRA, ANSM, and AGES and each one had their nuances and difficulties - primarily the level of pre-clinical/bench testing required, the detail of the investigator brochure, and the clinical investigation plan. Each competent authority approached the review in a different way, with each placing importance on different areas of the submission. These nuances led to the publication of MEDDEV 2.7/2 rev 2 for guidance on how competent authorities will assess your clinical investigation application for active devices and medical devices. This provides an element of harmonisation across competent authorities.

Justyna-Wanda Niewiadomski, MBA Thank you

Rob Packard To answer Malcolm's question, approval of the study from the competent authority is required prior to studies--just like in the USA for IDE submissions. The difference is that you have many countries in EU and only one FDA, while the FDA's process is more formal in structure and content. The CE Marking comes after you submit your Design Dossier and Clinical Study Summary Report to the Notified Body.