May 28, 2026
The first notable change lies in the very structure of the CSP. The new Chapter I (Articles R.5211-1 through R.5211-13 of the CSP) moves away from the approach of transposing the former European Directives (90/385/EEC and 93/42/EEC) and instead aligns directly with the European Regulation:
In practice, the key points to remember are:
Article R. 5211-3 of the CSP confirms that the labeling, instructions for use, EU declaration of conformity, and safety notices must be written in French for any device placed on the market in France. This provision, which has been retained and clarified, is now expressly based on Article 10(11) of the MDR, thereby providing it with a stronger legal foundation.
No major changes on this front; the main changes concern the requirements for updating previously filed returns.
The Executive Director of the ANSM establishes the format of the reports required by law, as well as the deadlines and procedures for their submission.
Operators are now required (Articles R. 5211-6 through R. 5211-8 of the CSP) to:
Please note: If a report is incomplete, the reporter has thirty days from the date of notification by the ANSM to complete it; otherwise, the report will be deemed inadmissible.
In line with existing regulations governing the dispensing of medications and the validity of prescriptions, and following the measures authorized during the COVID-19 pandemic, pharmacists may now, on an exceptional basis, dispense medical devices even after a prescription has expired, for a maximum period of three months, in order to prevent any interruption in chronic treatment.
Note: This option is, however, strictly regulated (initial treatment of at least three months, products not excluded by ministerial order, first dispensing within one month of the prescription’s expiration) and must be documented, with notification to the prescribing physician.
While much of the previous provisions have been retained, the text nevertheless introduces several significant changes, driven by the RDM, which strengthen the structure and traceability of health vigilance.
The first major change lies in the adoption of the vocabulary and categories derived from the European regulation. This new terminology facilitates better alignment with European post-market surveillance mechanisms and promotes the harmonization of vigilance practices among Member States.
In line with this harmonization effort, Article R. 5212-5 of the CSP now explicitly states that the manufacturer’s medical device vigilance contact person may be based in another EU Member State.
The new text expressly states that medical devices manufactured and used within the same healthcare facility, as referred to in Section III of Article L. 5211-3 of the Public Health Code, are subject to device vigilance as soon as they are put into service.
This clarification is important: the obligation to monitor medical devices applies even when the device is not placed on the market, provided it is used internally by the facility that manufactured it. The text thus clarifies the starting point for this obligation, linking it not to marketing but to the actual use of the device within the facility.
The 2026 decree strengthens the involvement of all economic operators (“EOs”) involved in the medical device supply chain. The new Article R. 5212-6 of the Public Health Code now requires the designation of a medical device vigilance liaison officer by :
Previously, this requirement applied primarily to manufacturers and healthcare facilities.
The new Article R. 5212-11 of the CSP expands the responsibilities of local medical device safety correspondents. Notable changes include:
The new Article R. 5212-18 I, 1° now requires that the inventory of medical devices include:
The previous provisions required only the retention of the serial number. The implementation of the IUD/UDI system provided for in Article 27 of the MDR now enables harmonized identification of devices across Europe and facilitates:
One of the most significant provisions of the decree concerns the traceability of implantable devices ( Articles R. 5212-33 through R. 5212-45 of the CSP).
While this requirement is not new—since obligations had already been in place since Decree No. 2004-802 of July 29, 2004—the implications of the PIP case, which underpin the traceability requirements established by the Medical Device Regulation (MDR), further strengthen the procedures and, above all, the retention periods for data related to the traceability of these devices.
The goal is twofold: to ensure individualized monitoring of the devices in use and to enable a rapid response in the event of an incident, particularly when it is necessary to contact the affected patients directly.
The decree requires pharmacists to record, in electronic form, the Unique Device Identifier (UDI), the date the device was dispensed to the user department, and the identification of that department (Rule 5212-37 of the Public Health Code).
The decree also specifies that this traceability system complies with the European framework governing the protection of personal data, in particular the General Data Protection Regulation (GDPR).
Patients thus have the right to access, correct, and restrict the processing of their data. However, they may not object to the processing of this data, given the public health objectives pursued by the system (Article R. 5212-36 of the Public Health Code).
When it comes to data retention, the text truly breaks new ground:
These deadlines, which stem from past healthcare scandals, pose a major logistical and IT challenge for healthcare facilities.
The decree incorporates provisions regarding the restoration to working order (“RBEU”) of single-use medical devices (Articles R. 5212-47 through R. 5212-54 of the CSP), codifying the provisions of Decree No. 2025-247 of March 17, 2025. This practice, distinct from refurbishment as defined by the MDR, allows certain devices to be given a second life.
The decree sets out the practical details: the RBEU is now strictly reserved for centers and professionals certified by an accredited body (such as COFRAC) for a period of four years.
This certification requirement, which will become mandatory no later than September 1, 2027, marks a departure from previous, largely unregulated practices and ensures the highest level of patient safety.
Following the 2022 legislative order, the decree establishes a two-tier penalty system:
Under criminal law
With regard to financial penalties
Article R. 5461-4 of the CSP identifies new violations by a manufacturer or its authorized representative that are subject to penalties imposed by the ANSM:
These financial penalties, which vary in severity depending on the nature of the violation, give the ANSM greater enforcement powers and serve as a deterrent.
Note: The previous law did not provide for such specific financial penalties for these violations, which constitutes a major change in the new legislation.
Although the 2022 regulations had slightly modified the provisions regarding advertising, the 2026 decree on medical devices makes no mention of this.
Only the decree concerning DMDIVs specifies that, among the mandatory disclosures in professional advertising, the “class” of the DMDIV must be indicated, rather than the “list” on which the DMDIV appears, pursuant to Article R. 5221-6 of the CSP (amendment to Article R. 5223-2(3) of the CSP).
Please note: As of now, the CSP does not provide for any adjustments to consumer advertisements regarding the CEXXXX label required by European regulations, nor does it provide for adjustments to the labels for devices covered by Annex XVI.
The decree on in vitro diagnostic medical devices (“DMDIV”) follows a similar approach to that adopted for medical devices, adapting the regulatory provisions of the Public Health Code to the requirements of Regulation (EU) 2017/746 (“IVDR”).
Several points are worth noting.
First, the decree confirms the language requirements applicable to IVDs placed on the market or put into service in France. The labeling, instructions for use, certain information regarding the operation or use of the device, the EU Declaration of Conformity, and safety notices must be written in French.
The decree also sets out the rules for reporting business activities to the ANSM. It specifies the procedures for filing, updating, and periodically confirming the reported information, as well as the obligations in the event of cessation of business or a change in the SIRET number. If a report is incomplete, the reporting party has thirty days to complete it; otherwise, the report is deemed inadmissible.
The text also specifies the cooperation obligations of economic operators. The manufacturer, its authorized representative, the importer, or the distributor must, at the request of the competent authorities, provide the information, documents, or samples necessary to verify compliance with the obligations set forth in the IVDR (Articles R. 5222-1 et seq. of the CSP):
Reporting requirements are also specified. Healthcare professionals and trained staff working for prevention organizations or associations must report serious incidents without delay. Patients, accredited patient organizations, non-professional users, and other third parties may also report incidents or serious incidents of which they are aware. The text further provides for specific coordination with pharmacovigilance for incidents related to companion diagnostic devices.
A special exemption for establishments that manufacture and use their own devices: The decree specifies their reporting obligations to the ANSM (activity report, supporting documentation, compliance with the general safety and performance requirements of the regulation).
Another significant change concerns the traceability of certain rapid diagnostic tests (RDTs) and self-testing kits when they are performed or dispensed outside of healthcare facilities. The professionals concerned must record and store electronically the data necessary to identify the person concerned, the device used or provided, and the date of performance or dispensing. These provisions will take effect on a date set by decree, and no later than January 1, 2027.
Notably, the Director General of the ANSM is expressly designated as the competent authority in the event of a dispute regarding the classification of a DMDIV. This clarification reinforces the national authority’s role in applying the classification rules set forth in the IVDR.
Most of the decree took effect the day after its publication in the Official Journal, on April 22, 2026.
However, the provisions regarding the specific traceability rules applicable to implantable devices, insofar as they apply to community pharmacists, will take effect on September1, 2026 (Section 5 of Chapter II of Title I of Book II of Part Five of the CSP).
The certification scheme for restoring buildings to a usable condition, meanwhile, has a transition period that runs until September1, 2027 (Article 4 of Decree No. 2026-299 of April 17, 2026).
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