The European Medical Device Nomenclature (EMDN) aims to support the functioning of the European database on medical devices (EUDAMED) in accordance with Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Among its various uses, it will be used by manufacturers for the registration of medical devices in EUDAMED, where it will be associated with each unique device identifier (UDI-DI).

As the EMDN serves mainly regulatory purposes to support MDR and IVDR requirements, it also plays a key role in the documentation and technical documentation of MDR/IVDR devices, the sampling of technical documentation performed by notified bodies, post-market surveillance, vigilance, and post-market data analysis, etc. It is intended to support all actors in their activities under the MDR/IVDR and provides patients with key descriptions of devices regarding their own devices and all other devices available on the market and registered in EUDAMED.

The EMDN is accessible and downloadable in pdf and excel format by following this link: webgate.ec.europa.eu/dyna2/emdn

Source : https://eu-udi.zendesk.com/hc/fr/articles/360020878877-Qu-est-ce-que-la-nomenclature-europ%C3%A9enne-des-dispositifs-m%C3%A9dicaux-

IUD-IP information is not required to appear on the AIDC label on the retail packaging if the device is sold exclusively at a retail point of sale. The MDR 2017/745 excludes IUD-IP information from the AIDC format at the point of sale packaging level, however, the exception does not apply to the HRI, which must be identified on the point of sale packaging. The mentioned exception is defined for the sales packaging level only, so the primary packaging level must comply with the IUD requirements as defined in the MDR (IUD-ID and IUD-IP in AIDC and HRI formats).*

Source: Frequently Asked Questions – Unique Device Identification (UDI) Helpdesk
https://eu-udi.zendesk.com/hc/fr – UDI FAQ Factsheet (2022)

The UDI-DI is a unique numerical or alphanumeric code specific to a device model and is also used as an “access key” to information stored in a UDI database. The UDI-DI must be unique at each level of device packaging.

This mandatory and fixed part of a UDI identifies the specific product and packaging configuration of a manufacturer.

The UDI-DI is assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to provide a UDI-DI to identify a device used on a patient when a UDI-DI does not appear on the device label.

For example: if the lowest basic packaging level with an identified UDI has a device number greater than 1, a UDI-DI must be assigned.

If the device is not directly marked and the basic quantity of the device is greater than one, the UDI-DI must be provided in EUDAMED.

The issuer of the UDI-DI unit code is the same as the UDI-DI.

The same UDI-DI can be used for multiple devices.

In accordance with Annex VI, Part C, Section 1, the UDI-DI is defined as follows: The UDI-DI is used to associate the use of a device with a patient in cases where a UDI is not placed on the individual device at the level of its unit of use, for example, when multiple units of the same device are packaged together. *

Source: Frequently Asked Questions – Unique Device Identification (UDI) Helpdesk https://eu-udi.zendesk.com/hc/en – UDI FAQ Factsheet (2022)

The IUD support (Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI) of the IUD) must be present on the label or on the device itself and on all higher levels of the device’s packaging.

If there are significant space constraints on the unit packaging, the IUD support may be placed at the higher packaging level.

The higher packaging levels must have their own unique IUD. Please note that shipping containers will be exempt from this requirement.

The IUD must appear in a plain text/human-readable information (HRI) version and in a form that uses AIDC technology. AIDC refers to any technology that transmits the unique device identifier or device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process. The HRI consists of readable characters that can be easily read by people.

If there are significant constraints on the use of both AIDC and HRI on the label, only the AIDC format must appear on the label.

For devices intended for use outside of healthcare facilities, such as home care devices, HRI must appear on the label even if it results in no room for AIDC.

For other specific requirements related to the IUD support, please refer to section 4 of Annex VI, Part C, of the two regulations.

For single-use medical devices of class I and IIa medical devices and Class A and Class B IVD medical devices that are individually packaged and labeled, the IUD support is not required to appear on the packaging, but it must appear on a higher packaging level, such as a carton containing multiple devices (individually packaged). However, when the healthcare provider is not expected to have access, in cases such as home care, to the higher packaging level of the device, the IUD must be placed on the packaging (of the individual device).

For devices exclusively intended for retail sale, AIDC IUD-IPs are not required to appear on the point-of-sale packaging.

If the IUD support is easily readable or, in the case of AIDC, scannable, through the device’s packaging, the placement of the IUD support on the packaging is not required.

Source : Unique Device Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/74601/08/2020

https://health.ec.europa.eu/medical-devices-topics-interest/unique-device-identifier-udi_fr – FAQ relative au système IUD

Currently, article R. 5212-13 of the French Public Health Code (CSP) stipulates that any manufacturer of medical devices, or their representative, must appoint a medical device vigilance correspondent and communicate their name to the Director General of ANSM.

This provision is subject to change with the forthcoming publication of the implementing decrees of the DM and DMDIV ordinances. However, if maintained, it will continue not to apply to distributors or importers.

Source: https://ansm.sante.fr/documents/reference/faq-reglement-dm-divers#correspondant_vigilance

Article R. 5222-10 of the Public Health Code states that any health cooperation user of in vitro diagnostic medical devices, healthcare professionals, manufacturers or their representatives, importers and distributors, as well as any blood transfusion establishment, must declare a local “reactovigilance” correspondent to the ANSM. This provision includes medical biology and anatomopathology laboratories.

This provision may be subject to change with the upcoming publication of the DM and DMDIV ordinances.

Source: https://ansm.sante.fr/documents/reference/faq-reglement-dm-divers#correspondant_vigilance

In accordance with Article 87 of the Medical Devices Regulation (MDR) and Article 82 of the In Vitro Diagnostic Medical Devices Regulation (IVDR), the manufacturer must notify the competent authorities concerned via Eudamed or national means (Article 123 of the MDR or Article 113 of the IVDR) of the following incidents:

any serious incident involving devices placed on the European Union market, with the exception of expected side effects that are clearly documented in the product information and quantified in the technical documentation and which are subject to trend reporting under Article 88;

any corrective safety measure taken with regard to devices placed on the Union market, as well as any corrective safety measure taken in a third country concerning a device that is also legally placed on the European Union market, where the reason justifying the measure does not concern exclusively the device placed on the third-country market.

Therefore, when the manufacturer considers that the incident reported to them is a serious incident, they must make a declaration in Eudamed (Article 87, paragraph 11).

Source: https://ansm.sante.fr/documents/reference/faq-reglement-dm-declaration

No, each operator has their own obligations and responsibilities towards the competent authorities. Manufacturers have reporting obligations regarding post-market surveillance and vigilance. These obligations do not replace those of distributors, and vice versa. Distributors have their own reporting obligations to the competent authorities in situations where a serious risk is identified. The reporting requirements for distributors are set out in Article 14 of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), and those for manufacturers in Articles 10, as well as 87 and 88 (MDR) or 82 and 83 (IVDR).

Source: https://ansm.sante.fr/documents/reference/faq-reglement-dm-declaration

The status of the software or application is defined by its intended use and the processing of incoming data.

The intended use, also known as the claim, is determined by the manufacturer (the publisher) of the application. It is described in the instructions, labeling, and promotional material.
Not all software and applications used in the healthcare field fall under the status of DM or DMDIV. The qualification of software requires a case-by-case evaluation of the intended use and specific characteristics of each to determine the medical purpose of the product.
Here’s what to remember:
To be classified as a DM or DMDIV, the software must meet the following cumulative criteria:
Be intended for medical purposes as defined by the definition of DM or DMDIV. For example, it should allow for diagnosis, diagnostic assistance, treatment, or treatment assistance.

Provide a result specific to the benefit of a single patient.
Perform an action on incoming data, such as analysis to provide new medical information. For example, an application for analyzing physiological signal data specific to a patient and with medical alert functions will be classified as a DM. This action must be different from storage, communication, or a simple search such as a database or digital library integrating data for the exclusive purpose of archiving without exploiting them.

The purpose of this type of application is to improve adherence to a treatment in a patient, i.e., the correspondence between a patient’s treatment adherence (e.g., regular medication intake) and the doctor’s prescription. The patient can track their medication intake and manage reminder settings through their smartphone or email. The software allows for adherence reports to be sent to the treating physician, as well as planning and managing appointments with healthcare professionals.
Tracking a patient’s adherence and sending medication reminders does not constitute a medical purpose under Article 2 of Regulation 2017/745.

Source : https://ansm.sante.fr/documents/reference/le-logiciel-ou-lapplication-sante-que-je-vais-mettre-sur-le-marche-releve-t-il-du-statut-de-dispositif-medical-dm-ou-de-dispositif-medical-de-diagnostic-in-vitro-dm-div

The criteria for classifying a medical device are:

• Its intended purpose
• The mode of action on the patient (invasive/active)
• The duration of use
• The site of application

Accessories are classified independently of the devices they are associated with.

In accordance with Article R.5211-20 of the French Public Health Code, which transposes point 4 of Article 4 of Directive 93/42/EEC and point 4 of Article 4 of Directive 98/79/EC into French law, the labeling of a medical device provided to the end user or patient, the accompanying instructions, as well as any other information related to its operation or use must include a version written in French.

When an operator wishes to market a CE-marked medical device and assigns it a new intended use in order to market it under their own name, this medical device constitutes a new product and must undergo a new CE marking procedure in compliance with Directive 93/42/EEC.

Indeed, in accordance with the definition of the manufacturer provided in paragraph f of Article 1 point 2 of the aforementioned directive, the obligations of the directive that apply to manufacturers also apply to the natural or legal person who assembles, packages, processes, refurbishes and/or labels one or more prefabricated products and/or assigns them the intended use of a device in order to place them on the market under their own name.

The confidentiality of our clients’ data is one of our core values. To ensure we fully meet your needs, we can draft a confidentiality agreement that will apply from the beginning of the project.

In accordance with articles L.5211-4 and R.5211-66 of the French Public Health Code, which transpose article 14 of Directive 93/42/CEE into French law, the data identifying Class IIa, IIb, III medical devices and active implantable medical devices must be communicated to the ANSM upon their entry into service on French territory.

We can indeed offer “training packages” that group several training sessions in the same day, as long as the duration of the selected training sessions does not exceed half a day.

We offer a meeting with our sales representatives and trainers in order to better understand your needs for your projects. This way, we can quickly send you a relevant proposal.

For in-house training, we can welcome you in our premises or come to your establishment if you wish.
Inter-company training is organized in our headquarters in Orsay (91), France.

CEISO is an accredited training organization. Therefore, if you are entitled to training rights, the training we offer can be fully refunded by your OPCO.

A training day usually runs from 9am to 5pm with a lunch break – a meeting shared with the trainer. However, since each training is different, we invite you to consult our training catalog in which you will find a detailed program for each of them.

In order to be present to help companies wishing to expand their markets, we are competent to accompany you in several areas outside Europe: Asia (China, Japan, Taiwan) but also the Pacific, North America (USA, Canada…), MEA (Lebanon, Tunisia, Ivory Coast).

This depends on several factors:

• Senior management, who lead the initiative.
• The resources they are willing to allocate to this process, both internally (human resources) and externally (outsourcing some of the work to a specialized firm).
• The quality and completeness of the documents presented.
• The responsiveness of the competent authorities in different markets.
• From several weeks to a few months.

This situation is common. A CE marking certificate issued by a Notified Body for a Class I device is not required, except for Class I devices with a measuring or sterile function. However, it is essential to establish a Quality Management System for the general organization of the company, according to the requirements of the EN ISO 13485 standard, which you can have certified (voluntary process).

A CE marking certificate attests to the conformity of a device with regulatory requirements. It can only be issued by a Notified Body for a period of three to five years, in accordance with point 11 of Article 11 of Directive 93/42/EEC on medical devices.

A quality certificate attests to the conformity of a company’s general organization and does not alone justify the regulatory conformity of a device. It can be issued by a Notified Body or a Certification Body.

Internal audits, like audits by Notified Bodies or certification bodies, must be conducted by personnel trained in audit practices, according to the principles of a recognized standard.

This standard provides guidance on the principles of auditing, their implementation, as well as the necessary competence of auditors.

In the interest of full transparency, we want our clients to understand our process, even before the project starts. That’s why, along with your commercial proposal, we provide you with a “proposal for support in implementing a quality management system.” This document will present your specifications, the key points of the mission, the details of the intervention steps, as well as a confidentiality clause.

The duration for the conservation of administrative data mentioned in Article R5211-26 is:

• At least 5 years
• At least 15 years, after the manufacture of the last unit of the product in the case of implantable devices.

A CRO – Contract Research Organization – is a service provider company specialized in the management of clinical trials. Our clinical department, MediaClin, has CRO status. We offer clinical evaluations adapted to your medical devices and your strategy. The clinical evaluation can be bibliographical or can involve a clinical trial.

The Research Tax Credit (CIR) covers our company’s research activities. It entitles you to a tax reduction.

“Clinical data” refers to all safety and/or performance information generated from the clinical use, in humans, of the medical device.
The evaluation of clinical data allows for confirmation of compliance with requirements regarding the characteristics and performance of the device under its normal conditions of use, as well as the evaluation of adverse effects and the acceptability of the benefit/risk ratio. It enables compliance with the Essential Requirements of European Directives.

Clinical evaluation includes:

• scientific literature reviews (bibliographies)
• clinical investigations (pre-marketing or post-marketing, reimbursement, etc.)

We offer a meeting with our account managers to best target your needs for your projects. This way, we can quickly send you a relevant proposal.