Medical Market Access by Merc
Merc will deal with all the strategy path for the market access in the easiest/fastest way, providing support for the following activities:
- Preliminary evaluation of Regulatory strategy path.
- Identification of the best regulatory strategy to reach the market in the easiest/fastest way.
- Proposal of different regulatory strategy with pro and contra for each of them.
- Compile a Technical File with evidence of compliance to the Regulation 2017/745 on Medical Device (or the Regulation 2017/746 on in vitro diagnostic medical devices).
- Submit the technical file to the Notify Body and receive a CE Mark certificate if medium or high-risk device.
- Appoint an Authorized Representative if you have no physical location in Europe.
- Register your medical devices with the Competent Authorities in the different European Countries (for Class I medical device it is necessary device national notification).
- Develop and Maintain a Post market surveillance System according to the Regulation 2017/745 on Medical Device (or the Regulation 2017/746 on in vitro diagnostic medical devices) and single nations requirements.
- Develop and Maintain of a Vigilance System in accordance with Regulation 2017/745 on Medical Devices (or to Regulation 2017/746 on in vitro diagnostic medical devices) and single nations requirements.
- Define and develop the company Quality Management System according to the requirements of the ISO 13485: 2016 standard and the Regulations.