Medical devices are classified into four classes depending on their characteristics and safety profile (e.g. invasiveness , dependence on a source of energy, duration of contact with the body):

• class I, less critical, includes most of non-invasive medical devices which are not dependent on a source of energy, such as patches or glasses, and contains also two other sub-classes:
  • class Im (medical devices having a measuring function, such as thermometers);
  • class Is (sterile medical devices);
• class IIa, medium-risk, includes medical devices which could be invasive and dependent on a source of energy but do not interact dangerously with the body, such as contact lenses or tracheal tubes;
• class IIb, medium/high-risk, includes medical devices that interact dangerously with the body, such as ureteral stents or blood bags;
• class III, high-risk, includes most of implantable medical devices or medical devices interacting with the functions of vital organs or containing drugs or animal derivatives, such as coronary stents, joint implants, prosthetic heart valves or breast implants.

Medical devices can be marketed in Europe after obtaining the CE certification, which guarantees that they are compliant with the essential requirements established by the European legislation. CE certification is issued by an accredited Notified Body, with the only exception of class I medical devices (non-sterile and without measuring function) that can be certified directly by the Manufacturer in view of their low risk.

In Italy, the Manufacturer (or its authorized representative in Europe) must register the medical devices in a dedicated database of the Ministry of Health before they are put into the market. The same requirement applies also to medical device kits, that must be registered into the same database by the Assembler. The data entry can be delegated to a third party.

Many pieces of information should be entered into the database, including name and code of the medical device, its classification (class, GMDN code, etc.), name of the Manufacturer or its authorized representative, a brief description of the medical device together with its intended use, a list of the materials contained in the medical device that comes into direct contact with the patient, sterilization data, information about re-use, scientific bibliography and other information. The CE certification must also be uploaded into the database, together with a safety data sheet and the whole packaging (box, labels and instructions for use, if present). All the information included on the packaging (box, labels and instruction for use, if any) should be in Italian. Multilanguage packaging is also acceptable if it includes the Italian language.

The registration of the medical devices in the sub-database Repertorio, in order to allow the healthcare professionals of the National Healthcare System to access all the information on the medical device entered into the database, is also advisable in the case of participations to public tenders.

The new Regulations on medical devices and in-vitro diagnostic medical devices were published in the Official Journal of the European Union on May 5th, 2017 and now replace the existing Directives.

The new Regulations contain a series of extremely important updates, such as the reinforcement of the criteria for designation and processes for oversight of Notified Bodies, the revision of risk classification rules for medical devices and the introduction of a new risk classification system for in vitro diagnostic medical devices, improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification, the strengthening of post-market surveillance requirements for manufacturers and improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.

The new rules will apply after a transitional period, namely 3 years for medical devices and 5 years for in vitro diagnostic medical devices.

A proper planning of the activities is advisable. Regulatory Pharma Net team and experts are available to support companies to comply with the new requirements.

The presence of at least a Person Responsible for Regulatory Compliance (PRRC) is one of the new regulatory obligations introduced by the Regulation (EU) 745/2017 for Manufacturers and European Representatives of medical devices marked according to the Regulation.

The presence of at least a PRRC is in any case recommended also for Manufacturers and European Representatives of medical devices marked according to the previous Directive 93/42/EEC and who benefit from the grace period up to May 26^th, 2024.

The PRRC is responsible for ensuring the conformity of medical devices with the quality management system, the update of technical documentation and EU declaration of conformity, the fulfilment of obligations relating to vigilance and post-marketing surveillance, and the fulfilment of obligations relating to clinical investigations in case of investigational devices.

The PRRC shall have:

• a formal qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
• or alternatively four years of professional experience in regulatory affairs or in quality management systems relating to medical devices without any particular formal qualification.

The PRRC shall be available permanently and continuously and must have decision-making autonomy in relation to his/her own competences and responsibilities. It is also possible to assign the role of PRRC to more than one person, provided that each has the required qualifications and that the respective competences and responsibilities are established in the respective appointment forms (so-called joint and several liability is excluded).

The role of PRRC can be delegated to a third person outside the company only for SMEs with less than 50 employees and annual turnover less than € 10M.

The identity of the PRRCs should be reported by the company in the EUDAMED.

Regulatory Pharma Net (RPN) is available to provide your company with any updates on the medical device regulatory framework and to assist on all regulatory needs related to medical devices.

Feel free to contact us at info@regulatorypharmanet.com

The Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) require the demonstration of compliance with the General Safety and Performance Requirements (GSPRs) for medical devices and in vitro diagnostic devices.

In line with the provisions of MDR Article 61 (1) and IVDR Article 56(1), the clinical/performance evaluation should be appropriate in view of the device claims and characteristics.

In case the demonstration of conformity with GSPRs based on clinical data is not deemed appropriate, the manufacturer shall demonstrate conformity based on the results of performance evaluation, bench testing, preclinical evaluation, and usability assessment.

Usability testing aims to verify how the user interacts with a device and is a key part of overall device risk management and safety, ensuring that the device is safe and effective for the end users. Notably, the approval of a device is frequently deferred or even rejected if the manufacturer does not provide sufficiently positive usability testing data.

Usability tests can also aim to assess the usability and appeal of the device that have commercial relevance but are outside of regulatory expectations

Usability testing should be managed according to the intended use environment and intended users of the device, taking into consideration for example whether the device might be used in a hospital or at home, by health professionals or unskilled patients or caregivers, etc. Intended users are asked to perform specific tasks with the device, in order to evaluate its interactive qualities. Desirable interactive qualities include attributes such as ease of learning, ease of use, and avoidance and recovery from a possible misuse.

Usability testing should include four main steps:

1. planning (defining test environment, representative users and goals, and developing a test protocol and other documents required)
2. recruiting
3. test conduction (including evaluation of the users’ interactions with the device and final interview)
4. analysis of the results and findings.

Regulatory Pharma Net (RPN) is available to provide your company with any updates on the device regulatory framework and to assist on all regulatory needs including the conduction of usability tests for your medical devices and in vitro diagnostic devices.

Feel free to contact us at info@regulatorypharmanet.com

The MDR requires manufacturers of class IIa, class IIb, and class III devices to prepare and submit a Periodic Safety Update Report (PSUR) at least annually for each medical device. Manufacturers of class I devices do not have to prepare a PSUR: instead, they should prepare a Post-Market Surveillance (PMS) Report.

PSUR is a report that summarizes the results and conclusions of the analysis of post-market surveillance data gathered as a result of the PMS Plan for medical devices. PSUR must be updated whenever there are new safety information or significant changes in the benefit/risk assessment of the device. Manufacturers are required to submit PSURs for medical devices through the EU database EUDAMED, ensuring PSURs are in compliance with EUDAMED requirements, annually for class IIb and class III devices and every two years for class IIa devices. Manufacturers of legacy devices should not submit PSUR in EUDAMED but should make it available upon request to Competent Authorities and Notified Bodies.

The MDCG 2022-21 “Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)” of December 2022 provides valuable information on how to prepare a PSUR that meets the requirements of the MDR. This guidance is applicable to medical devices which have been certified under MDR or MDD 93/42/EEC or AIMDD 90/385/EEC. It does not apply to in vitro diagnostic medical devices which have been certified under IVDR (EU) 2017/746 or IVDD 98/79/EEC.

MDCG guidance also includes a template for the presentation of data in the PSUR, that offers a recommended structure for presenting the PSUR, designed to ensure that the information required by the MDR is included in a complete and consistent manner, with specific sections for device description, post-market surveillance data, Field Safety Corrective Actions (FSCAs) and Corrective and Preventive Actions (CAPAs) initiated, and other relevant information, simplifying the preparation of PSURs by Manufacturers and also the review process by competent authorities.

Regulatory Pharma Net (RPN) has extensive experience in regulatory affairs and can provide expert advice on how to meet regulatory requirements, being available to provide your company with any updates on the device regulatory framework and to assist on all regulatory needs including the preparation of PSURs for your medical devices.

Feel free to contact us at info@regulatorypharmanet.com

The MDCG 2024-1 – Guidance on the vigilance system for CE-marked devices document, recently endorsed by the Medical Device Coordination Group, brings forth significant updates to the vigilance system for CE-marked medical devices.

Aimed at harmonizing vigilance reporting, the guidance offers a detailed framework for manufacturers on how to report individual serious incidents, implement periodic summary reporting, and understand the nuances of trend reporting. The guidance emphasizes the importance of reporting any serious incidents to the relevant Competent Authority. It also outlines the option to report similar serious incidents involving the same device or device type within the context of a Periodic Summary Report. Additionally, the guidance covers Trend Reporting of any statistically significant increase in the frequency or severity of incidents that are not serious incidents or expected undesirable side effects. With its emphasis on detailed incident reporting and the utilization of IMDRF terminologies for categorized adverse event reporting, MDCG 2024-1 represents a pivotal step towards enhancing the regulatory oversight of medical devices within the EU.

Regulatory Pharma Net (RPN) is available to provide your company with any updates on the medical device regulatory framework and to assist on all regulatory needs.

Feel free to contact us at info@regulatorypharmanet.com