Understanding the nuances of the classification of medical devices according to European regulation is a crucial step for biotechnology innovators, researchers and engineers.
If you work in the field of medical devices this guide aims to clarify the criteria and procedures that determine how your device is classified in the EU, based on the risk system to assess the vulnerability of the human body and the risks associated with the devices, affecting everything from product design to its market launch.
With explanations on basic terms, the classification procedure, and clarifications on specific rules, this article aims to help manufacturers navigate the complex regulatory framework to ensure the safety and efficacy of medical devices.
WHY IS MEDICAL DEVICE CLASSIFICATION IN EUROPE IS CRUCIAL?
Before going any further, let's ask ourselves: why is it so important to properly classify a medical device?
The answer is simple yet fundamental: classification directly influences the regulatory path a medical device must take before it can be safely used by healthcare professionals and patients. It determines the level of conformity assessment required, the requirements for technical documentation, and post-market surveillance procedures. In other words, adequate classification is the first step towards successful and responsible innovation in the health sector.
UNDERSTANDING THE EU CLASSIFICATION SYSTEM
The European classification system categorizes medical devices into four main categories based on the risk they present:
Class I, IIa, IIb, and III, with Class III representing the highest-risk devices.
Criteria include, but are not limited to, intended use duration, invasiveness, dependence on a source of energy, and whether the device is intended to administer and/or remove drugs or other substances from the body.
MEDICAL DEVICE CLASSIFICATION METHODOLOGY ACCORDING TO EUROPEAN REGULATION
Determining the Medical Purpose:
Precisely identify the medical purpose of the medical device in accordance with Article 2 of the medical device European regulation. This includes specifying the manufacturer's intentions of use, including but not limited to diagnosis, prevention, monitoring, treatment, or mitigation of a disease.
Evaluating the Duration of Use:
Classify the medical device's duration of use as transient (less than 60 minutes), short term (between 60 minutes and 30 days), or long term (more than 30 days).
Characterization of Invasiveness and Energy Source:
Assess the degree of invasiveness of the medical device and determine if it depends on a source of energy. Active devices, for example, often require a more thorough evaluation.
Considering Measurement Functions and Systems Procedures:
Examine whether the medical device has a precise measurement function and is used as part of specific systems or procedure packs.
Applying Classification Rules:
Use the rules established in Annex VIII of Regulation (EU) 2017/745 to classify the medical device. In case of multiple applicabilities, the highest rule prevails.
Technical Documentation and Justification:
The technical documentation must include the device's risk class and justify the chosen classification rules application.
AN OVERVIEW OF THE MEDICAL DEVICE CLASSIFICATION RULES FROM 1 TO 22 ACCORDING TO THE MDR
The classification of medical devices in Europe is guided by a set of detailed rules, ranging from Rule 1 to Rule 22, each addressing different aspects and potential risks associated with the use of devices. Here is a brief overview of these rules:
Rules for Non-Invasive Devices
Rule 1:
Covers non-invasive devices in contact with intact skin, mainly used for protection.
Rule 2:
Applies to non-invasive devices used for the channeling or storage of blood, bodily fluids, etc.
Rule 3:
Concerns devices that modify the biological or chemical composition of the body.
Rule 4:
Targets devices in contact with injured skin, with different subcategories depending on the severity and type of injury.
Here is a synthetic flowchart of the European classification rules for non-invasive devices:
Rules for Invasive Devices
Rules 5 to 8 :
Deals with invasive devices for transient, short, and long-term uses, depending on their application location and duration of use.
Here is a synthetic flowchart of the European classification rules for invasive devices:
Rules for Active Devices
Rules 9 to 13 :
Concerns active devices, including those used for therapy, diagnosis, control of physiological processes, and the administration or removal of drugs or other substances.
Here is a synthetic flowchart of the European classification rules for active devices:
Special Rules
Rules 14 to 22 :
Address specific categories of devices, such as those incorporating medicinal substances, used for contraception or the prevention of sexually transmitted diseases, specifically disinfectants, for recording diagnostic images, manufactured with tissues or cells of human or animal origin, and those containing nanomaterials, among others.
Here is a synthetic flowchart of the special European classification rules for certain specific devices.
Each of these rules was designed to ensure that medical devices are appropriately classified according to the level of risk they present to patients and users. This classification directly influences the level of regulatory control and conformity assessment required before these devices can be placed on the European market.
THE ROAD TO COMPLIANCE
Once the classification is established, the path to compliance and the European market becomes clearer.
For Class I devices, the manufacturer can self-certify compliance.
For higher classes, the involvement of a notified body is necessary, notably for obtaining CE marking, adding additional steps to the conformity assessment process.
CONCLUSION
The classification of medical devices is a complex journey that requires close collaboration between manufacturers, notified bodies, and regulatory authorities.
For biotechnology professionals, researchers, and engineers, understanding this process is crucial to innovate responsibly in the health field.
Whether your interest lies in developing revolutionary technologies or studying the regulatory framework of medical devices, this guide is an essential starting point for navigating European regulatory waters.
This article is not a document of the European Commission and cannot be considered as reflecting the official position of the European Commission.
References and Texts :
[1] European parliament and the council of the european union, “REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices.” Accessed: Feb. 13, 2024. [Online]. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
[2] “MDCG 2021-5 Guidance on standardisation for medical devices,” Medical Devices. Accessed: Feb. 13, 2024. [Online]. Available: https://health.ec.europa.eu/system/files/2021-04/md_mdcg_2021_5_en_0.pdf
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