I work for a company that makes human cell tissue products from non-viable human tissue. Primarily it is human bone allograft for the spine market and achilles tendons. They were considering entering the EU market, but now the new MDR would appear to require a clinical investigation. I think they have largely abandoned the project. I'm curious how many people think this segment of the industry will have the necessary clinical investigations to support CE marking? Is my company unique or is this fairly typical of the tissue banking industry? I suspect in the end some extension will have to be made to allow the continued marketing of the products, as the necessary clinical investigations will not have been completed. On the other hand, those that complete the work have the potential to capture significant market share.