Background & Regulations

The manufacturer must first compile technical documentation proving the quality, safety and performance of the device (clinical data, test results, elements linked to the manufacturing process...)

Depending on the risk class, the manufacturer freely chooses a Notified Body (NB) from among the European NBs authorized for the DM category concerned (List of NBs according to Regulation (EU) 2017/745 available on the European Commission website). This body is responsible for conducting this conformity assessment (with the exception of certain class I DMs, where this responsibility may be deferred to the manufacturer).

Two types of evaluation must be carried out:

Product evaluation (technical, pre-clinical, clinical component)

• Verification that the product meets safety and performance requirements
• Evaluation covering design, compliance with technical standards and benchmarks, pre-clinical data (biological technical testing,), clinical data analyzed as part of a clinical evaluation ( literature, clinical studies/investigation....)
• Compilation of elements in technical documentation

Assessment of the quality management system (smq)

• Verification of the company's ability to mass-produce devices in compliance with regulatory requirements.
• The manufacturer sets up a QMS describing all associated processes (change management, risk management, manufacturing processes, etc.) and compliance.

After evaluation, the notified body issues a medical CE marking certificate valid for up to 5 years.

This certificate authorizes the manufacturer to market its device on the European market.

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Once on the European market, manufacturers of CE-marked devices continue to be assessed by the notified body:

• Annual surveillance audit ;
• In-depth audit when CE marking is modified or renewed ;
• Unannounced audits (at least every 5 years);
• Complete re-evaluation of technical documentation at the time of any modification or renewal of CE marking

A post-market clinical follow-up plan (pSCAC or PMCF plan - Post Market Clinical Follow-up plan) must be established and then implemented after CE marking has been obtained in order to describe the activities to be carried out to close any compliance gaps identified during clinical evaluation and/or to collect data to be considered at the time of the next update.

Pre-market assessment has been strengthened:

• The scope of application has been clarified and extended to devices with no medical purpose (contact lenses, dermal fillers, liposuction products, lipolysis, lipoplasty...)
• The classification rules have evolved, leading to numerous upward reclassifications, notably for complex electronic or implantable devices. As a reminder, the determination of the risk class conditions the steps required to obtain CE marking, the choice of evaluation procedure, as well as the clinical requirements needed: the higher the class, the stricter the level of evidence required.
• In addition to changes concerning the clinical evaluation strategy, requirements relating to performance, benefit and safety claims have also been strengthened:
  • New essential requirements have been introduced, such as justification for the use of hazardous substances (CMR, PE) or for cyber safety;
  • Class III implantable devices must be reviewed by a panel of European experts, prior to CE marking.
• Complete revision of technical documentation for all products, notably with the addition of a new document annexed to the clinical evaluation, summarizing safety and clinical performance characteristics, intended for publication in the EUDAMED database after validation by the Notified Body (NB).
• New obligations imposed on economic operators: a qualified person must be appointed at the manufacturer's premises (and his authorized representative) to ensure compliance with the regulations.

Clinical evaluation is now central to marketing authorization:

• Clinical evaluation by clinical investigation is mandatory for Class III and implantable devices, barring duly justified exceptions (e.g. devices already marketed by the same manufacturer, use of equivalence demonstrated and approved by the notified body (NB), devices based on well-established technology). The use of equivalence is now very strict, with a strong requirement for biological equivalence, and reinforced criteria for technical and clinical equivalence.
• More rigorous demonstration of performance and safety is required: the regulation of clinical investigations tends to align with that applicable to medicinal products for clinical trials.
• Notified bodies are subject to a strict European framework, with reinforced assessment of their competence according to rigorous specifications, as well as the possibility of unannounced inspections at manufacturers' sites.

Once the device is on the market, monitoring requirements are also strengthened:

• Regulation 2017/745 requires the manufacturer to have a post-marketing surveillance plan: manufacturers must mandatorily produce periodic safety update reports (PSURs), documenting the benefits/risks observed in the field and any corrective actions. In particular, this surveillance plan must incorporate an ongoing clinical evaluation update process, through which the manufacturer proactively collects and evaluates post-market clinical data.
• The vigilance mechanism has been strengthened with the establishment of a European incident database (EUDAMED), accessible to the public. This database provides better knowledge of the market, product information, incidents and clinical investigations, and offers the possibility of verifying the regularity of a given product's presence on the market.
• Traceability is improved thanks to the introduction of the Unique Device Identifier (UDI) registered in EUDAMED, as well as the obligation to provide a patient implant card for the devices concerned.

In the event of technical modification or extended use (e.g. targeting new targeted arrhythmias), an additional regulatory assessment is required.

• Regulations on medical devices (MD) and in vitro diagnostic medical devices ANSM
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
• HAS SANTE Guide pratiques DM