MDR COMPLIANCE

The first version of the European Medical Device Nomenclature (EMDN) was released by the European Commission on May 4^th, 2021.

EMDN aims at supporting the functioning of EUDAMED (see Art. 26 of MDR 2017/745 and Art. 23 of IVDR 2017/746). Among its various uses, it will be used by manufacturers for the registration of medical devices in EUDAMED, where it will be associated to each UDI-DI.

EMDN has an alphanumeric structure that is established in a seven-level hierarchical tree. The 1° hierarchical level refers to Categories. The 2° hierarchical level refers to Groups. The further five hierarchical levels (3°, 4°, 5°, 6°, 7°) refer to Types.

EMDN is accessible to all stakeholders, free of charge. However, to find out the proper EMDN code for each product in portfolio it could be time-spending and not so easy for manufacturers.

MeDGloX Added Values

The MeDGloX database helps manufacturers to find out their products proper EMDN codes in a quick, easy, error and hassle free way.

In the MeDGloX database users (manufacturers, importers, dealers, buyers, etc) can find more details since it includes six additional hierarchical levels (8°, 9°, 10°. 11°, 12°, 13°) referring to Types. Hence, the MeDGloX database is ideal for competition check and market reasearches on technical aspects.

Thanks to the above unique characteristics, the MeDGloX database can help manufacturers and notified bodies to meet some important regulatory requirements provided by the MDR.

Indications for manufacturers

Regulation (EU) 2017/745 on medical devices (MDR) requires evidence and data for those medical devices that manufacturers intend to place on the EU market. The searchable database, developed by MeDGloX , supports manufacturers in researching similar devices to meet various regulatory requirements.

For example, by querying the database it is possible to obtain information on similar products through the grouping provided for by the EMDN nomenclature, in order to get evidence of the knowledge of the state of the art of the technology manufactured or in order to search in a targeted manner the pertinent literature data for the verification and validation of the product to be included in the technical documentation.

Here are some regulation requirements for which MeDGloX offers a solution. For this purpose, the extracts from the regulation are indicated in quotation marks and the most interesting information is highlighted in bold.

A) SUPPORT FOR THE IDENTIFICATION OF THE STATE OF THE ART

(Annex I, chapter I, paragraph 1 – GENERAL REQUIREMENTS)

“1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.”

B) SUPPORT FOR THE EDITING OF THE TECHNICAL DOCUMENTATION

(Annex II – TECHNICAL DOCUMENTATION)

“1.2. Reference to previous and similar generations of the device
(a) an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;
(b) an overview of identified similar devices available on the Union or international markets, where such devices exist”.

B.1) THE TECHNICAL DOCUMENTATION INCLUDES THE CLINICAL EVALUATION REPORT

(Article 61 – Clinical evaluation)

“3. A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:
(a) a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied:
– it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relate, in accordance with Section 3 of Annex XIV, and
– the data adequately demonstrate compliance with the relevant general safety and performance requirements;(b) a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and
(c) a consideration of currently available alternative treatment options for that purpose, if any”.

ANNEX XIV

“3. A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated. The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:
– Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements”.

B.2) TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

(Annex III)

“The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.
1. The post-market surveillance plan drawn up in accordance with Article 84.
The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.
(a) The post-market surveillance plan shall address the collection and utilization of available information, in particular: […]
– publicly available information about similar medical devices.
(b) The post-market surveillance plan shall cover at least:
— a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;”

C) FOR IMPLANTABLE AND CLASS III DEVICES, MANUFACTURER SHALL DRAW UP THE SUMMARY OF SAFETY AND CLINICAL PERFORMANCE

(Article 32 – Summary of safety and clinical performance)

“2. The summary of safety and clinical performance shall include at least the following aspects:
(a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
(b) the intended purpose of the device and any indications, contraindications and target populations;
(c) a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device;
(d) possible diagnostic or therapeutic alternatives;
(e) reference to any harmonised standards and CS applied;
(f) the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up;”

D) RE-CERTIFICATION

(Annex VII – REQUIREMENTS TO BE MET BY NOTIFIED BODIES)

“For re-certification, the manufacturer shall “to submit a summary of changes and scientific findings for the device, including:
(a) all changes to the originally approved device, including changes not yet notified,
(b) experience gained from post-market surveillance,
(c) experience from risk management,
(d) experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I,
(e) experience from reviews of the clinical evaluation, including the results of any clinical investigations and PMCF,
(f) changes to the requirements, to components of the device or to the scientific or regulatory environment,
(g) changes to applied or new harmonised standards, CS or equivalent documents, and
(h) changes in medical, scientific and technical knowledge, such as:
— new treatments,
— changes in test methods,
— new scientific findings on materials and components, including findings on their biocompatibility,
— experience from studies on comparable devices,
— data from registers and registries,
— experience from clinical investigations with comparable devices”.

Indications for notified bodies
In the same way as indicated for manufacturers, the MeDGloX database can also be a useful tool for notified bodies in order to make easier some of their activities under the regulation, with particular reference to those activities provided for in the monitoring and re-assessment of the notified body. For example, the responsible authority for notified bodies reviews an appropriate number of technical documentation, in
particular the clinical evaluation documentation, to verify the conclusions drawn by the notified body.
Some extracts of interest from the regulation are indicated below.

A. A CONSULTATION AND VERIFICATION TOOL TO IDENTIFY DEVICES SIMILAR TO THOSE PRODUCED BY THE MANUFACTURER

(Annex VII – REQUIREMENTS TO BE MET BY NOTIFIED BODIES, 4.10. Surveillance activities and post-certification monitoring)

“The notified body shall, if listed as part of the conditions for certification:
— conduct an in-depth review of the clinical evaluation as most recently updated by the manufacturer based on the manufacturer’s post-market surveillance, on its PMCF and on clinical literature relevant to the condition being treated with the device or on clinical literature relevant to similar devices,Moreover, about re-certification procedure, the notified body verifies the summary provided by the manufacturer which includes, among others, changes in medical, scientific and technical knowledge, such as:
— new treatments,
— changes in test methods,
— new scientific findings on materials and components, including findings on their biocompatibility,
— experience from studies on comparable devices,
— data from registers and registries,
— experience from clinical investigations with comparable devices”.

B. IN THE CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION

(Annex IX, Chapter II – ASSESSMENT OF THE TECHNICAL DOCUMENTATION)

“4.5 The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity”.

C. IN THE CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION

(Annex X, paragraph 3 – Assessment)

The notified body shall:
(d) in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be similar or equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity”.