Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

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Article L1126-8

French Public Health CodeIn force

Updated 8 Nov 2023

The promoter is responsible for compensating for the harmful consequences of the performance study for the person taking part in it and their dependants, unless it can prove that the damage is not attributable to its fault or to the fault of any other party involved, without it being possible to invoke the action of a third party or the voluntary withdrawal of the person who had initially agreed to take part in the performance study.

If the promoter is not liable, the victims may be compensated under the conditions set out in article L. 1142-3. 1142-3.

All performance studies, with the exception of those which do not involve any risk or constraint and in which all procedures are carried out and products are used on a routine basis, require the promoter to take out insurance covering its civil liability as set out in this article and that of all participants, regardless of the nature of the relationship between the participants and the promoter. The provisions of this article are a matter of public policy.

The liability insurance cover referred to in the previous paragraph covers the financial consequences of claims arising from a performance survey, with the exception of those which do not involve any risk or constraint and in which all procedures are carried out and products are used on a regular basis, provided that the first claim is made to the insured or its insurer between the start of the performance survey and the expiry of a period of at least ten years from the end of the survey. If the person who took part in the performance study is under eighteen years of age at the time the study is completed, this minimum period runs from the date of his eighteenth birthday.

For the application of this article, the State, when acting as promoter, is not obliged to subscribe to the insurance obligation provided for in the third paragraph of this article. It is, however, subject to the obligations incumbent on the insurer.

Mariela Petrova

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Common Questions

Working with a corporate lawyer in France — Q&A

Any time a strategic decision changes how the company is owned, governed or contractually bound — incorporation, fundraising, M&A, restructuring, shareholder agreements, or major commercial contracts. Earlier engagement always costs less than later remediation.

A notary (notaire) is a public officer who authenticates specific deeds (mainly real-estate transfers and certain family-law acts). A corporate lawyer (avocat) advises on strategy, negotiates and drafts company documents, and represents you in disputes. The two roles complement rather than overlap.

Yes — most of our clients are foreign suppliers, investors or holding entities. We bridge the gap between French law and your home jurisdiction's expectations and deliver everything bilingually.

The SAS (Société par Actions Simplifiée) is the default choice for most international structures: flexible governance, single shareholder allowed, no minimum capital, and works cleanly with foreign holding entities. We assess SARL, SA, SCI on the merits when the situation calls for it.

Yes — communications with a French avocat are protected by the secret professionnel (Article 66-5 of the Law of 31 December 1971). This protection is broader than the common-law attorney-client privilege and applies to written and oral exchanges.

We work on fixed fees for clearly scoped engagements (incorporation, contract drafting, audits) and on monthly retainers for ongoing advisory. Hourly billing is the exception, not the default. You always know the cost before work starts.

Typical timeline is 2–3 weeks from KYC kick-off to RCS registration, assuming standard documentation. Holding-company structures, foreign-shareholder identification or in-kind contributions can extend this — we flag the gating items at the first meeting.

Absolutely. We routinely coordinate with your in-house counsel, expert-comptable or notaire — pragmatic collaboration is the norm, not the exception. We send them everything they need to do their part without duplicating work.

Mariela Petrova

Mariela Petrova

Avocate au Barreau de Paris

Toque #C2396

15+ Years In Corporate Practice

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Communications protected by professional secrecy — secret professionnel de l'avocat, Article 66-5 of the Law of 31 December 1971.

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