The article provides a general overview of the regulatory requirements for medical devices intended to be marketed and used in France
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The National Agency for the Safety of Medicines and Health Products (ANSM) has published an official notice dedicated to the revised regulatory framework for general and in vitro diagnostic medical devices. The document provides additional clarifications and recommendations to be taken into consideration by the parties involved in operations with such products in order to ensure compliance with the relevant regulatory requirements.
Introduction
In 2017, the European Union concluded an extensive revision of its regulatory framework for medical devices (MD) and in vitro diagnostic medical devices (IVDMD). The main goals of this reform were to strengthen health safety across the EU, ensure harmonized application of rules in all member states, and encourage innovation through a more accessible and transparent legal structure. One of the key simplifications introduced by the new regulations is the deployment of a centralized European information system known as EUDAMED, designed to improve communication, traceability, and oversight.
The updated framework resulted in two new cornerstone legislations: Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. These were officially published in the Official Journal of the European Union on May 5, 2017.
Timeline for Implementation and Transitional Provisions
The implementation of these new regulations has been planned over a multi-year timeline, allowing for a smooth transition from the previous regulatory directives. The Regulation (EU) 2017/745 became fully applicable on May 26, 2021. From this date, the affixing of a Unique Device Identifier (UDI) on the labels and packaging of implantable medical devices and Class III devices became mandatory.
Subsequent key milestones include the invalidation of the final certificates issued under the former directives, which will occur on May 27, 2024. One year later, by May 27, 2025, all devices placed on the market under the previous directives must either be withdrawn or comply fully with the new regulations. A final important date is May 27, 2027, when coordinated evaluations of multi-state clinical investigations will become obligatory.
Due to the COVID-19 pandemic, the original application date was postponed by one year to provide stakeholders with additional time for adaptation. Transitional measures were established to maintain the validity of certificates issued under the earlier directives until 2024, provided they meet specific criteria. A consensus interpretation of these transitional rules was made publicly available on the website of CAMD (Competent Authorities for Medical Devices).
Core Features and Innovations of Regulation (EU) 2017/745
The new regulation builds upon the foundational principles of the “new approach” system – particularly the CE marking system – but introduces a wide range of new obligations, safeguards, and oversight mechanisms. One of the most significant changes is the extension of the regulation’s scope to include certain non-medical products listed in Annex XVI. These include items that operate similarly to medical devices and pose comparable risks, even though they are not intended for medical purposes. At the same time, certain categories, such as probiotics, have been explicitly excluded.
The regulation introduces a clear requirement for manufacturers and their agents to designate a responsible person who ensures compliance with all regulatory requirements. This move enhances accountability within organizations and brings European regulations closer in line with global standards. Importers and distributors – including pharmacies and large retailers – must also fulfill new obligations, such as verifying regulatory conformity and maintaining proper documentation.
Notified bodies, which are third-party organizations tasked with assessing the conformity of devices, are now subject to stricter European-level control. Their competency requirements have been raised significantly, and they must adhere to new operational obligations such as unannounced audits of manufacturers and random product testing. These changes aim to harmonize assessment practices across the EU and prevent inconsistencies between member states.
Another important advancement is the creation of a European coordination group, enabling close collaboration among national competent authorities for market surveillance and clinical oversight. The vigilance system has been substantially improved with the establishment of a centralized database for incident reporting, and manufacturers are now obligated to produce periodic safety update reports (PSURs) under the supervision of notified bodies.
The regulation also strengthens requirements for pre-market evaluations. Manufacturers must now provide additional justification for the use of substances identified as carcinogenic, mutagenic, or toxic for reproduction (CMR), as well as for substances that are endocrine disruptors (PE). Cybersecurity concerns are explicitly addressed as part of essential safety requirements. For certain categories of devices – such as those based on absorbed substances or new implantables – additional consultation procedures with competent authorities in the field of medicinal products are required. Moreover, for new Class III implantable devices, notified bodies must consult a panel of European clinical experts before granting CE certification.
It is also important to mention that healthcare institutions are now subject to limitations in producing their own devices, a practice now restricted to addressing unmet medical needs. Similarly, the reprocessing of single-use medical devices is only permitted in member states that have chosen to allow this practice.
The regulation further improves transparency and traceability. EUDAMED, once fully operational, will provide public access to key information, including the regulatory status of devices and summaries of characteristics for Class III devices. This empowers patients, professionals, and authorities with clearer oversight.
Determining Product Qualification and Classification
Establishing the regulatory status of a product – whether it qualifies as a medical device, an in vitro diagnostic device, a medicine, a cosmetic, or personal protective equipment (PPE) – depends on a case-by-case analysis of its characteristics. Two primary factors are assessed: the intended purpose (as defined by the manufacturer in labeling, instructions, and promotional materials) and the product’s composition and mode of action.
A product qualifies as a medical device if it is intended for specific medical purposes such as diagnosis, treatment, prevention, or compensation for injuries or disabilities. These devices function through mechanical, physical, or software-based means rather than pharmacological or metabolic action. This definition also includes devices used in the design or maintenance of medical products and items meant for cleaning or sterilizing medical devices.
By contrast, a product is considered an in vitro diagnostic medical device (IVDMD) if it is used to analyze samples from the human body, primarily for the purpose of providing information about physiological or pathological states, congenital abnormalities, or compatibility with specific treatments. This also includes devices used to determine donor-recipient suitability, such as blood typing or HIV testing.
Some devices can fall under dual classifications, for example, combining the characteristics of a medical device and personal protective equipment. Products without a clear medical purpose, even if used in healthcare settings, are excluded from the MD and IVDMD definitions.
Classification Rules for Medical and In Vitro Diagnostic Devices
The classification of medical devices is based on their intended purpose, the level of risk posed to users or patients, and their degree of invasiveness. Devices are divided into four classes: Class I for low-risk devices such as eyeglasses and crutches; Class IIa for moderately invasive devices like contact lenses and dental crowns; Class IIb for higher-risk items including condoms and disinfection products; and Class III for the highest-risk devices such as heart stents and hip implants.
Only Class I non-sterile, non-measuring, and non-reusable surgical instruments can be marketed without the intervention of a notified body. All other classes require some level of external conformity assessment.
For in vitro diagnostic devices, the classification system also follows a risk-based approach, ranging from Class A (e.g., sample containers) to Class D (e.g., HIV or blood group tests). As with MDs, higher-risk IVDMDs require assessment by notified bodies, while Class A non-sterile IVDMDs are exempt from such intervention.
Non-Medical Devices Regulated under Annex XVI
The regulation also covers certain non-medical devices with risk profiles similar to MDs, such as colored contact lenses, dermal fillers, liposuction equipment, and devices emitting high-intensity light used for aesthetic procedures. These devices are classified using the same criteria as traditional MDs and must comply with relevant common specifications as laid out in Commission Implementing Regulations (EU) 2022/2346 and 2023/1194.
Regulation of Software and Digital Applications
The exponential growth of health-related software and mobile applications has prompted stricter oversight. Applications with a defined medical purpose are classified as MDs or IVDMDs and must comply with applicable regulatory requirements, including CE marking and post-market surveillance. The regulatory framework provides guidance to help determine whether a digital product meets the criteria for medical device status.
Traceability Measures and ANSM Recommendations
Traceability of medical devices in healthcare institutions is governed by Decree No. 2006-1497 and the decree of January 26, 2007, which establish a legal framework for matériovigilance. These rules aim to ensure quick and reliable identification of medical devices for patient safety and informed care. Europharmat, in collaboration with ANSM, developed a guide to support effective traceability systems in hospitals, including those in the military and cosmetic surgery sectors.
Devices such as programmers or remote monitoring accessories for implantables are treated as medical devices but are exempt from traceability obligations if they do not meet the implantability criteria defined in existing legislation.
The ANSM advises manufacturers and distributors to implement unique coding systems and detachable labels that include essential product details like name, manufacturer, lot or serial number, and to utilize barcodes (1D or 2D) for accuracy and simplicity. These recommendations aim to standardize traceability practices and reduce the risk of errors in clinical settings.
Conclusion
In summary, the information published by the authority addresses the key aspects pertaining to the existing regulatory framework for general and in vitro diagnostic medical devices, and is intended to navigate the parties involved within the main regulations and guidelines.
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