Medical device regulatory affairs
The field of medical devices is regulated by complex and constantly evolving regulations. With the entry into force of the European Regulation 2017/745 (MDR medical devices) and the European Regulation 2017/746 (IVDR), it is essential to guarantee full compliance of the products with the requirements required for placing them on the market.
Eumed® offers expert and specialized support for regulatory affairs, providing assistance and support at all stages.
We have recorded more than 50 thousand articles of every kind and class in the Medical Devices Directory of the Ministry of Health. We can offer immediate support to manufacturers and distributors to help them obtain the stock number for their products within a few days.
CE marking
The placing on the market of a medical device is subject to obtaining the CE marking, except for some specific exceptions provided for by law. This mark certifies the conformity of the device with the essential requirements established by Regulation (EU) 2017/745 (MDR) for medical devices and by Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic devices.
The manufacturer is primarily responsible for the conformity of the medical device and must ensure that it meets all applicable requirements, in particular those listed in Annex I of the MDR and in the previous legislative decrees 46/97 and 37/2010 (which implement Directive 2007/47/EC). This process involves the preparation of a complete technical file, which includes data relating to the design, manufacturing, risk assessment and clinical evidence of the device.
Eumed®, thanks to twenty years of experience in the regulatory sector, supports manufacturers at every stage of the certification process, offering strategic and operational support for obtaining the CE marking. In addition to the initial certification, we guarantee continuous assistance for maintaining compliance over time, and for the management of regulatory obligations deriving from the evolution of the European legislative framework.
Medical device classification
The correct classification of medical devices allows you to determine the applicable regulatory requirements and the most appropriate certification path. The European Regulation 2017/745 (MDR) and the European Regulation 2017/746 (IVDR) establish rigorous criteria to assign the risk class of a device based on its intended use, duration of application and level of invasiveness.
Eumed® supports customers in accurately identifying the risk class of their devices, ensuring an assessment compliant with current regulations. Furthermore, we take care of the attribution of the CND code (National Classification of Devices), mandatory for registration in national databases. It is important to note that CND was chosen as the basis for the European Medical Device Nomenclature (EMDN), used within the MDR for the registration of medical devices.
Our team of experts can assist customers in obtaining EMDN, MDA, MDT and MDS classifications for the European Union, ensuring that the device is registered and cataloged in accordance with European regulations. This approach ensures efficient management of the classification process, facilitating access to the European medical device market.
Clinical investigations
The clinical investigations are essential for demonstrating the safety and performance of products before they are placed on the market or for new indications of use, and are now also regulated by Regulation (EU) 2017/745 (MDR).
Per devices not bearing the CE marking, with CE marking for a use other than that under study, it is mandatory to submit an application to the Ministry of Health before starting the clinical investigation.
The application must be accompanied by a favorable opinion from a Territorial (CET) or National (CEN) Ethics Committee, valid throughout the national territory and binding for all centers involved in the study.
For class III devices or implantable devices, a specific authorization from the Ministry of Health is required, issued after an in-depth technical-scientific evaluation. The standard timeframe for this assessment is 45 days from validation of the application, extendable by a further 20 days if expert advice is required. During this period, the Ministry may request clarifications or additions to the sponsor, temporarily suspending the evaluation deadlines.
Eumed® offers complete support in managing clinical investigations on medical devices, assisting manufacturers in preparing the necessary documentation, interacting with the competent authorities and complying with current regulations, to ensure an efficient path towards the authorization and conduct of clinical trials.
Thanks to a strategic partnership (MED DEVICE LAB scarl – consortium company between La Sapienza University of Rome and Confindustra Dispositivi Medici) and to a
deep knowledge of European regulations, we offer complete assistance in the phases of:
- Planning: preparation of the CIP and documentation (IB, CRF, plan
monitoring, agreements and labelling). - Startup: recruitment of subjects and start of data collection according to the protocol
established. - Monitoring and Compliance: continuous supervision, risk management and compliance
of privacy. - Any Suspensions/Interruptions: protocol for suspension or closure
of the investigation. - Closing and Reporting: producing a final report and keeping it for a long time deadline of the documents for any checks
Registration of medical devices
The placing on the Italian market of medical devices and in vitro diagnostic medical devices requires registration in the Medical Device Database of the Ministry of Health. This obligation extends to manufacturers, assemblers, importers and other economic operators involved in the distribution of such devices.
Eumed® offers complete support for the registration of medical devices in the Ministry of Health Repertoire, ensuring efficient and accurate management of the necessary documentation. Our team of experts assists clients in collecting and verifying the required information, ensuring that all data is complete, consistent and compliant with current regulations.
Furthermore, with the entry into force of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), the EUDAMED European database, designed to centralize information on medical devices and economic operators at the level of the European Union.
What is Eudamed?
The art. 33 of the MDR Regulation and art. 30 of the IVDR Regulation provides for the establishment of European Device Database per following purposes:
- allow the public to be adequately informed about the devices placed on the market, the related certificates issued by the notified bodies and the economic operators involved
- enable the unique identification of devices in the internal market and facilitate their traceability;
- enable the public to be adequately informed about clinical investigations and sponsors of clinical investigations to meet their obligations with respect to DMs and performance studies with respect to IVDs
- enable manufacturers to comply with information obligations
- enable the competent authorities of the Member States and the Commission to carry out their tasks in relation to this Regulation on an informed basis and to strengthen mutual cooperation.
The following electronic systems are part of Eudamed:
- the electronic system relating to the registration of devices
- at the UDI database
- the electronic system relating to the registration of economic operators
- the electronic system for notified bodies and certificates
- the electronic system for clinical investigations for medical devices and for studies of the performance of in vitro diagnostic devices
- the electronic system for vigilance and post-marketing surveillance
- the electronic system for market surveillance.
Eumed® supports manufacturers and other economic operators in the registration procedure in EUDAMED, assisting in the creation and management of the company profile, in the request for the Single Registration Number (SRN) and in the insertion of device data. Our aim is to ensure a smooth and compliant transition to the new European regulations, keeping clients updated on regulatory developments and ensuring that all registrations are carried out in a timely and efficient manner.
Eumed® is able to provide the necessary assistance for the correct device registration procedure in EUDAMED with its own access credentials to the system, and as a subcontractor of the manufacturer. Following the most recent evolutions of Eudamed’s computerized systems, our company is already able to communicate with the System through the expected IT protocols, speeding up the communication and registration process.
Labeling of medical devices
Labeling medical devices helps ensure the safe and effective use of products by end users. According to the Regulation (EU) 2017/745 (MDR), the information provided must be clear, legible and understandable for end users. This information must include details of the device identification, manufacturer, expected performance, conditions of use and any precautions or warnings.
Eumed® supports manufacturers, distributors and importers of medical devices in correct drafting of labels, instructions for use and regulatory symbols, ensuring both linguistic and graphic compliance with current regulations. Our support extends to manufacturers, distributors and importers of medical devices and in vitro diagnostic devices, ensuring that labeling complies with MDR requirements.
Furthermore, we assist in the management of Unique Device Identification (UDI), a system introduced by the MDR to improve the traceability of medical devices. The UDI must be applied both on the device and on all higher packaging levels, according to the specifications dictated by the regulation.
PRRC: Person Responsible for Compliance with the Regulations
The art. 15 present in Regulations (EU) 2017/745 and 2017/746 introduced the obligation for manufacturers and authorized representatives to equip themselves with one Person Responsible for Compliance with the Regulations (PRRC), establishing tasks and requirements. This figure is responsible for supervising the entire compliance process and ensuring that the organization complies with all the provisions of the European Regulations on medical devices and in vitro diagnostic devices.
What does PRRC do?
The PRRC must ensure that:
- the conformity of the devices is adequately controlled in accordance with the quality management system under which the devices are manufactured before the release of a device;
- the technical documentation and the EU declaration of conformity are drawn up and updated;
- the post-marketing surveillance obligations of the manufacturer are satisfied (art.10, paragraph 10);
- the reporting obligations set out in Articles 87 to 91 are satisfied;
- in the case of devices under investigation, the declaration referred to in Annex XV, chapter II, point 4.1 is issued
It is also responsible for providing information and documentation requested to the competent authorities and actively collaborating with them during any inspections.
It is important that this figure has appropriate skills and knowledge to effectively carry out his responsibilities and has the support and resources necessary from the organization to ensure continuous compliance with the legislation.
Skills for the person responsible for the legislation
- a diploma, certificate or other qualification obtained by completing university studies, or a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in the field of regulation or quality management systems relating to medical devices;
or
- four years of professional experience in the field of regulatory or quality management systems related to medical devices.
Manufacturers of custom-made devices can demonstrate the necessary skills by having at least two years of professional experience in the relevant manufacturing field.
Relations with Notified Bodies (ON)
The Notified Bodies are those bodies designated by a Member State of the European Union to carry out conformity assessment activities of in vitro medical and diagnostic devices pursuant to Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
For classes higher than the first (Ir, Is, IIa, IIb, III) the Notified Body is required to verify the conformity of the medical devices by evaluating the technical documentation and the manufacturer’s quality system, in order to ensure the safety and performance of the product
Over the years we have found that the greatest difficulty highlighted by companies is not so much satisfying legal requirements, but rather establishing an effective dialogue with the body responsible for verifying compliance.
This is why Eumed® offers complete support to companies in the medical device certification process, from the choice of the most suitable body to the interactions during the preliminary and audit phases and also in the interactions following certification.
Our intervention, thanks to the experience gained over the years and the preparation of our team, also includes the analysis of the findings and the definition of document changes and process necessary to achieve compliance.
Relations with the public administration
Economic operators operating in the medical device sector often find themselves dealing with the Public Administration, for example in terms of healthcare advertising, healthcare clearance or free sales certificate.
The Health Clearance is the necessary document that the importer must obtain in order to place medical devices produced by non-EU countries on the Italian market. In fact, these devices are monitored by the Health offices maritime, air and border (USMAF), as peripheral offices of the Ministry of Health, which carry out surveillance activities to protect public health.
The supervisory activity is carried out through three levels of verification (documentary, identity, material, including sampling for analysis purposes) to ascertain the compliance of the goods of health interest with the requirements and prescriptions established by national and European regulations. The supervisory activity ends with the final release of an import admission provision, the Health Authorization – NOS or with a non-import provision, in the event of failure to pass the checks.
Eumed® provides a specialized team that can assist you in the procedure for requesting this health authorization, thus speeding up the time it takes to import goods while awaiting checks. Furthermore, we also offer the registration service in the medical device database, necessary to be able to distribute the relevant devices once imported.
The Free Sale Certificate is required to be able to export medical devices outside the European Union. Italian manufacturers and agents can request this certificate from the Ministry, which issues it after verifying the documentation presented in support of the request.
Eumed® offers support in preparing the request and all the necessary documentation in order to obtain this certificate.
Healthcare Advertising
Health advertising, in Italy, is subject to obtaining authorization from the Ministry of Health and is regulated respectively by D.Lgs 137/2022, for medical devices, and from D.Lgs 138/2022, for in vitro medical devices. We at Eumed® we offer assistance in the procedure required to request this authorization.
The regulation concerns any type of means of dissemination and provides, in art. 7 of EU Regulation 2017/745, that advertising cannot be carried out using texts, names, trademarks, images and figurative or other signs that could mislead the user or patient regarding the intended use, safety and performance of the device. This is achieved, explains the standard, when for example functions and properties of which it lacks are attributed to the device, or incorrect impressions are created regarding the treatment or diagnosis, functions or properties of which the device lacks, or the user or patient is omitted to be informed about a potential risk associated with the use of the device according to its intended use, or a use of the device different from that declared in the intended use for which the conformity assessment was carried out is proposed.
Furthermore, the Ministry of Health has also found that manufacturers often include claims, images, references to clinical studies and/or statistical investigations and QR codes containing advertising messages in labels and instructions for use. This is an absolutely incorrect practice as Regulation 2017/745 which precisely regulates the content of labels and instructions for use does not provide for the possibility of inserting promotional messages.
Eumed® offers assistance in the correct drafting of documentation and promotional messages relating to the products to avoid incurring regulatory non-compliance and sanctions.