Marketing a non-CE-marked medical device: what are the conditions?

A medical device that is not CE-marked can be marketed under certain conditions, via a specific derogation.

The ANSM recently decided to simplify and standardize the application procedure to facilitate analysis and speed up processing times.

Authorization for non-CE-marked medical devices

Article 59 paragraph 1 of Regulation (EU) 2017/745 on medical devices (RDM) allows any competent authority, upon duly justified request, to authorize the placing on the market or putting into service of a DM for which CE marking procedures have not been applied.

This authorization is granted when use is deemed necessary in the interests of public health or patient health and safety.

In France,Article L. 5211-3 II of the Public Health Code (CSP) gives the Agence nationale de sécurité du médicament et des produits de santé (ANSM) the authority to grant this derogatory access.

In exceptional cases, the Director General of the ANSM may authorize the marketing and use of DM that do not comply with certification procedures (CE marking), provided that their use is justified by a public health benefit.

Authorization is granted either individually for a specifically identified patient, or globally for a given device, exclusively in France for a defined period.

The procedure for requesting exceptional access

Requests for exceptional access can now be made via the portal Simplified procedures and must include all the information required to assess the safety data and the expected benefit for the patient(s), in relation to the risks associated with failure to comply with the applicable standard procedures.

It is the manufacturer who must initiate this request and provide proof that the device meets all the following requirements, even if it has not been certified:

• ‍Thejustification of the need and interest for the patient(s): characteristics, context and medical condition etc.,‍
• The impossibility of including the patient in a clinical investigation,‍
• The absence of a CE-marked alternative device in the indication concerned or justification that it is impossible to use one, ‍
• The absence of a suitable and/or available therapeutic alternative (including medication or surgery) or justification of the impossibility of resorting to one, ‍
• Reasons for the absence of CE marking and details of the regulatory situation: previous CE marking, timetable if CE marking in progress or planned, etc.‍
• Safety and performance data: standards applied, summary of data from clinical and preclinical investigations, performance maintenance attestation, full preclinical test reports in the special case of "First in man"‍
• Information on the characteristics of the medical device: mode of action, sterility, expiration date, storage location, etc.,‍
• The declaration of conformity to the general safety and performance requirements, except for the aspects covered by the derogation, accompanied by a certificate confirming that all necessary precautions have been taken to protect the health and safety of the patient(s),
• ‍Thequalitative and quantitative assessment of derogations already granted, as part of a global derogation request.

Example of a request: late renewal of CE marking

The delay in renewing CE marking, linked to the entry into force of the RDM, may justify a request for derogatory access when it concerns a device meeting an unmet medical need, in particular for patients in therapeutic deadlock.

The request must be solidly supported by clinical data proving its efficacy and safety, and by written requests from healthcare professionals underlining the validity of the request and the urgency of the situation for the patient(s) concerned.

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Stakeholder responsibility and post-access monitoring‍

The derogatory access route engages the responsibility of all stakeholders:

• ‍Themanufacturer remains responsible for the marketing of the DM and remains subject to its obligation of materiovigilance. It is required to report to ANSM any incident or risk related to the use of the device.
• The practitioner is responsible for choosing the therapeutic strategy, using the non-CE-marked medical device and informing the patient (free and informed consent).
• ‍The health care facility must implement procedures to ensure :
  • informing the players involved (department heads, pharmacist in charge of PUI, etc.),
  • tracking and tracing of non-CE-marked devices,
  • reporting to ANSM and the manufacturer any incident or risk of incident related to their use.

The ANSM has several prerogatives in this respect:

- Ask the manufacturer or healthcare professional for further information,

- Withdraw or suspend derogatory authorization, particularly in view of the risks to the patient,

- Impose specific conditions on the use of the device, such as restrictions on the number of beneficiary patients or additional clinical follow-up requirements.  

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Point of vigilance 

Derogatory access is an exceptional measure designed to meet urgent public health needs. It is not a permanent alternative to CE marking. The manufacturer must undertake to take the necessary steps to obtain certification, in particular by submitting a request for clinical investigation. Under no circumstances may this derogation be used to circumvent the conformity assessment, clinical investigation or marketing procedures.