Your expert in medical device regulations
Supporting manufacturers with medical device regulations to ensure safe and rapid access to national markets, including France.
Regulatory expertise serving medical device companies
BluePharm supports manufacturers in ensuring their products comply with regulations.
Our consultants draw on their in-depth knowledge of:
MDR 2017/745,
MDCG guidelines and HAS recommendations,
ANSM requirements and other local authorities for clinical trials and vigilance.
Our mission: to transform regulatory requirements into levers for success.
Clinical evaluation: demonstrating performance and safety from clinical support to market access
Clinical evaluation is central to CE marking, access to the French or European market, and the medical device life cycle.
BluePharm designs and supervises clinical evaluation plans (CEPs) tailored to each device class. We help you to :
effectively utilize scientific literature and post-market data,
plan the necessary clinical investigations,
draft clinical evaluation reports (CERs) that comply with MDR requirements and MDCG guidelines.
Our team helps you build a robust clinical dossier, ensuring the credibility of your claims and facilitating evaluation by the HAS or other bodies in Europe.
See article: Clinical development of digital medical devices: practical benchmarks from the HAS
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CE marking: sécuriser la conformité européenne
https://bluepharm.fr/en/ce-marking/BluePharm supports you in the CE marking strategy for your medical device, regardless of its risk class.
Our experts work with you to define the most appropriate compliance path for your innovation, taking into account your data history, your status as a manufacturer or authorized representative, and the requirements of your notified body.
We provide:
- drafting and reviewing the technical file in accordance with MDR 2017/745,
coordination of exchanges with the notified body,
and audit preparation to ensure certification without delay.
See article: CE marking of medical devices: exploding delays threatening innovation in Europe
Market access: national evaluation and reimbursement
Each European country has its own assessment procedures for recognizing the clinical and medico-economic value of medical devices.
BluePharm supports you in defining a clinical strategy tailored to national requirements, taking into account the assessment criteria in place in the main European markets.
Our experts help you to:
position the clinical evidence for your device in relation to national standards (France, Germany, Spain, etc.);
identify the specific expectations of evaluation agencies, particularly those of the HAS in France;
adapt the clinical evaluation plan to strengthen the relevance of the data for a future reimbursement application (LPPR, LATM, PECAN, or European equivalents);
promote consistency between your regulatory, clinical, and market access strategies.
Our goal: to help you prepare, right from the development phase, the evidence required by national authorities in order to facilitate recognition of the clinical benefits and value of your device in the various European markets.
Post-marketing vigilance and surveillance: ensuring safety and ongoing compliance
Market access is just one stage in the regulatory lifecycle of a medical device.
The MDR 2017/745 requires manufacturers to implement a robust and documented post-market surveillance (PMS) system, ensuring the collection, analysis, and use of real-world usage data.
BluePharm supports you in setting up and maintaining this system, working closely with your quality, clinical, and regulatory teams.
Our experts provide assistance with:
- design and update post-market surveillance plans (PMS Plan) and post-market clinical follow-up plans (PMCF Plan),
analyze field data and user feedback,
prepare periodic safety update reports (PSURs) and periodic monitoring reports (PMSRs),
Structure an effective vigilance process, including the detection, reporting, and handling of incidents in conjunction with the ANSM and other competent authorities. Subscription option available for this service.
Our approach aims to make PMS a tool that enables us to enhance device safety, inform clinical updates, and maintain CE compliance over time.
Navigating between European regulations and national requirements
Access to the European and French medical device markets is based on two dynamics:
- European, with compliance with Regulation (EU) 2017/745 (MDR) and obtaining the CE marking, which is essential for marketing in the European Union;
- National, with specific evaluation procedures for each country, such as those of the HAS in France (LPPR, LATM, PECAN) for the recognition and reimbursement of the device.
BluePharm supports you at every stage of this process:
- development of a regulatory and clinical strategy tailored to your risk class and target markets ;
compilation and optimization of technical and clinical dossiers in accordance with the MDR and MDCG guidelines;
preparation of the clinical elements required for national assessments (HAS, NICE, G-BA, etc.);
implementation of a post-market surveillance and vigilance system in accordance with European requirements;
coordination with the competent authorities and your European partners to ensure consistency in compliance and market access.
