FAQs

We support medical device manufacturers of all sizes—from startups in the early stages to established companies—across a variety of specialties: ophthalmology, cardiology, orthopedics, neurology, and many other areas of medical technology.

Yes, Isocèle Conseil is Qualiopi-certified for its training programs, a recognized mark of quality for our professional training services.

The MDR (Medical Device Regulation) is the European regulation governing the placing on the market of medical devices in the European Union. It replaced the previous directives (93/42/EEC and 90/385/EEC) and imposes stricter requirements regarding safety, clinical performance, and post-market surveillance.

MDR compliance requires comprehensive technical documentation (clinical evaluation, risk management in accordance with ISO 14971, biocompatibility in accordance with ISO 10993, software validation in accordance with IEC 62304, etc.), as well as a robust quality management system. Each requirement must be traced and justified to the notified body.

We provide support at every stage: drafting or revising your technical documentation, preparing for audits by notified bodies, responding to observations and nonconformities, developing biocompatibility strategies, creating V&V traceability matrices, establishing post-market surveillance procedures (PMS, PSUR, PMCF), and support during notified body transfers.

The timeframe varies depending on the device’s risk class, the completeness of your documentation, and the notified body’s workload. It can range from several months to more than a year for Class III or implantable devices. Receiving support early in the process can significantly reduce this timeframe.

The IVDR regulates in vitro diagnostic medical devices. It introduces a risk classification system (classes A through D) and requires, for most devices, the involvement of a notified body—a major change from the previous Directive 98/79/EC.

It depends on the device’s classification. Non-sterile Class A devices may be subject to self-certification, but the vast majority of devices (Classes B, C, and D) require the involvement of a notified body. We work with you to conduct this classification analysis.

We handle the preparation of the technical dossier, performance evaluation, clinical evidence strategy, risk management documentation, and monitoring of regulatory developments (MDCG guidelines, implementing acts).

The CE marking certifies that a medical device complies with the essential safety and performance requirements defined by the MDR or the IVDR, thereby authorizing its placement on the European market.

No. The CE certificate has a limited validity period (generally 5 years) and requires ongoing monitoring: periodic safety update reports (PSURs), post-market clinical follow-up (PMCF), and updates to the technical documentation in the event of changes to the product or regulations.

It is essential to plan for renewal several months in advance, particularly if there is a change in the notified body. Transitional provisions exist (Article 120 of the MDR), but they are strictly regulated. We can help you ensure you meet these deadlines.

• Preparation and Revision of Technical Documentation (MDR/IVDR)
• Responses to Observations and Nonconformities Raised by Notified Bodies
• Quality Management Systems (QMS) and Mock Audits
• Clinical Evaluation (CER/CEP), PMCF, PSUR
• Risk Management (ISO 14971), Biocompatibility (ISO 10993)
• International Regulatory Strategy (FDA, Health Canada, SFDA, etc.)
• Qualiopi-Certified Regulatory Training Courses
• European Authorized Representative (Article 11 of the MDR) for non-EU manufacturers

Yes. Beyond the European market, we assist certain clients with international regulatory issues, including FDA submissions (510(k), De Novo, Pre-Submission), Health Canada, Australia, and the Gulf markets.

Both. We handle everything from one-time assignments (responding to an audit finding, reviewing a document) to long-term support, acting as an outsourced Quality/Regulatory Manager.

We’ll start by discussing your project, its regulatory status, and your specific needs so that we can offer you support tailored to your situation and budget.

Not always. The MDR prioritizes a clinical assessment based on existing data (literature, equivalence, prior clinical experience) when such data are sufficient and justified. A dedicated clinical trial becomes necessary when the available data are insufficient to demonstrate safety and clinical performance, particularly for implantable, Class III, or innovative devices.

Demonstration of equivalence is possible under strict conditions (technical, biological, and clinical equivalence with a reference device, and guaranteed access to data for that device). The MDR has significantly tightened these requirements compared to the previous directive, and notified bodies review them with great rigor.

Post-market clinical follow-up is an ongoing requirement of the MDR intended to confirm, throughout the device’s lifecycle, that its safety and clinical performance remain consistent with the initial clinical evaluation. It provides input for updating the Clinical Evaluation Report (CER) and the risk management plan.

Yes, a dedicated clinical trial generally adds several months to several years to the timeline (design, regulatory and ethical approvals, recruitment, follow-up, analysis). That is why it is strategically important to assess as early as possible—right from the device’s design phase—whether an alternative clinical pathway (literature review, equivalence) is feasible.

This is assessed through a critical review of the available literature, a gap analysis against the requirements of Annex XIV of the MDR, and a review of the relevance of the data with respect to your target population and your claims. We conduct this type of analysis to ensure the soundness of the clinical strategy before any trial is initiated.

The choice depends on several criteria: the organization’s scope of accreditation for your type of device (some organizations are not designated for all classes or technologies), its current processing times, its availability, its industry experience in your field (implants, software, ICDs, etc.), as well as its location and working language. We can help you compare the organizations relevant to your application.

No. The number of notified bodies designated under the MDR/IVDR remains limited, and their processing times, documentation requirements, and levels of rigor can vary significantly. Some have waiting lists of several months even before the assessment begins.

Yes, a transfer of a notified body is possible and sometimes necessary (an overly demanding audit, incompatible deadlines, a body ceasing operations, etc.). This process involves a specific procedure and requires ensuring continuity of certification coverage. We have assisted several clients with this type of transfer.

Ideally, several months before the target deadline, particularly for Class IIb, Class III, or implantable devices, where demand far exceeds available supply. A technical dossier that is well prepared in advance also facilitates approval by the regulatory authority.