The IVDR_RG (UE) 746/2017 is the new regulation that establishes the rules related to placing on the market, making available on the market and putting into service the in vitro diagnostic medical devices for human use and accessories for such devices in the European Union.
The regulation understands an in vitro diagnostic medical device to be any medical device consisting of a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, appliance, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the study of specimens originating from the human body, including blood and tissue donations, solely or principally to provide information on one or more of the following:
- relating to a physiological or pathological process or condition
- relating to congenital physical or mental deficiencies
- relating to a predisposition to an ailment or disease
- to determine safety and compatibility with potential recipients
- to predict response or reaction to treatment
- to establish or monitor therapeutic measures. Sample containers shall also be considered in vitro diagnostic medical devices
At León Research, we have studied this regulation in depth and we can guide you throughout the adaptation process that must be followed to obtain or maintain the marketing authorization for in vitro diagnostic devices for human use in the EU.
MAIN ASPECTS TO TAKE INTO ACCOUNT:
The new regulation classifies in vitro medical devices and establishes classification rules to determine the product’s corresponding class.
Class A is the lowest risk and is where we find medical devices for general laboratory use, accessories without critical characteristics, instruments for in vitro diagnostic procedures or sample containers.
Class B presents a higher level of risk, such as pregnancy detection products, fertility tests, glucose detection products, etc.
In class C we can find medical devices with a higher level of risks such as those intended for the detection of the presence of a sexually transmitted agent or exposure to it, human genetic tests or the management of patients with a disease or condition that puts life in danger.
The highest level of risk is presented in class D where we find, among others, products intended to be used for the detection of the presence of, or exposure to, a transmissible agent that causes a potentially fatal disease and with a risk high or supposedly high spread or determination of the infectious load of a life-threatening disease when its observation is essential in the patient management process.
To comply with this reclassification process, it is important to know the aforementioned classification rules well, and at León Research, we are experts in this.
2. PERSON RESPONSIBLE FOR COMPLIANCE WITH THE REGULATIONS
A novelty in the new legislation is that it requires at least one person in the manufacturer’s organization who will be responsible for compliance with the regulations and for placing the medical device on the market.
3. AUTHORISED REPRESENTATIVE
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a single authorized representative. This will be responsible, among other things, for:
- verify that the EU declaration of conformity and the product’s technical documentation has been drawn up.
- verify that the manufacturer has carried out the relevant conformity assessment procedure.
- Keep at the disposal of the competent authorities a copy of the technical documentation, the EU declaration of conformity and, where applicable, a copy of the relevant certificate.
- Comply with the registration obligations laid down.
At León Research we provide the legal representation service for those manufacturers that are established outside the European Union, being able to cover this need whenever necessary.
4. IDENTIFICATION AND TRACEABILITY OF PRODUCTS
Traceability is central to the regulation and states that distributors and importers will cooperate with manufacturers to obtain an appropriate level of product traceability.
The Unique Device Identification (UDI system) allows the identification and facilitates the traceability of devices that are not custom-made or non-investigational devices.
Always before introducing a device on the market, the manufacturer will assign the product a basic UDI-DI.
From León Research’s pharmacovigilance and safety service, we ensure compliance with this requirement and ease the creation of the UDI system to guarantee adaptation to the legislation.
5. CONFORMITY ASSESSMENT
Before placing a product on the market, manufacturers shall carry out a conformity assessment of said product:
- The conformity assessment procedures for class A products must be carried out, as a general rule, under the sole responsibility of the manufacturers, since they present a low risk for patients.
- However, in the case of classes B, C and D products, an appropriate level of intervention by a notified body is mandatory.
- In the case of class D products, the competent authorities must be informed about the certificates issued by the notified bodies and must be given the right to verify the evaluation carried out by the notified bodies.
The certificates of conformity are valid for a maximum of 5 years and their validity may be extended for additional periods, based on a new evaluation.
In addition, notified bodies may place restrictions on the intended use of a product for certain groups of patients, or may require manufacturers to carry out specific post-marketing clinical follow-up studies.
Another of the traditional services that we offer at León Research is quality auditing and compliance assurance of research processes, and naturally, for in vitro diagnostic devices for human use, we also could contribute to this process.
6. POST-MARKET SURVEILLANCE
For each device, the manufacturer shall include a post-market monitoring system that is proportionate to the risk class and appropriate to the type of device. That system will be integrated into the manufacturer’s quality management system.
This system must collect data on the quality, performance and safety of a device throughout its life cycle to analyze and draw conclusions that can be used for any preventive or corrective action.
In class A and B products, the manufacturer prepares a report with the results and conclusions that may be made available to the notified body or the competent authority, when requested.
Manufacturers of Class C and D products, should prepare a periodic safety report summarizing the results and conclusions of the analysis of the post-marketing surveillance data collected in the post-marketing surveillance plan. Throughout the device’s life cycle, they will be recorded in the periodic report.
Finally, the manufacturers of class D products will submit the updated periodic safety report through an electronic system and the notified body will examine the report and enter its evaluation in the electronic system, indicating any action taken.
At León Research, we also carry out this monitoring from the pharmacovigilance and safety service, collecting all the necessary data on the product during its life cycle and we contribute to the analysis of this data and establish, together with the manufacturer, the preventive or corrective measures that might be necessary.
LEGISLATION, STANDARDS AND GUIDES – IVDR
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EECISO 14155:2020
ISO 14155:2020 _Good clinical practice_Medical devices
ISO 13485: 2018_Quality system
ISO 20916: 2019_In vitro diagnostic medical devices – Clinical performance studies using human specimens – Good study practice