In Europe, CE marking procedures assess both the medical device technical file and the manufacturer’s Quality Management System (QMS) to ensure compliance with applicable regulations; the same applies to the UKCA marking process in the UK. The situation is different in the US, where Pre-Market Notification (510(k)), De Novo Classification Request or Pre-Market Approval (PMA) is required to enter the US market, with varying QMS inspection timelines (pre or post market approval) depending on the submission type.
Technical dossiers provide comprehensive information about the product and quality assurance, enabling regulatory bodies to assess quality, safety and efficacy/performance in light of bench tests, preclinical and clinical data comparatively with the state-of-the-art as well as vigilance and post-marketing surveillance systems in place. The aim of the assessment is device certification or market authorization, which is when the company is allowed to lawfully market their products into applicable regions.
Commercial launch is prepared in parallel to registration. Based on registration labels and claims, the product’s value proposition is finalized, and the launch strategy is refined.
Client Goals
Compile, submit and manage device registrations
Finalize regulatory certification dossiers.
Detail roadmaps for submitting applications internationally.
Set up Risk Management Plan (RMP)
Finalize post-market surveillance and transition to post-marketing requirements.
Set up post-marketing surveillance plan if applicable.
Challenges
- What are the applicable procedures & requirements for registration in targeted markets?
- How to adapt registration applications to multiple international markets?
- How the vigilance system can meet all applicable international requirements?
- What are the key regulatory provisions in distributors’ agreements?
- Which market to focus on first?
- How to approach payers and purchasers?
- Are promotional materials regulatory-compliant?
- How to consolidate the product value dossier and prepare it for adaptation to local markets?
- How to prepare for negotiations with payers?
Solutions 
