The risk classification of medical devices is one of the key steps in the approval process in Europe under Regulation (EU) 2017/745 (MDR) and describes the classification of a medical device according to the potential risk to patients and users. This classification significantly determines the regulatory effort involved, from technical documentation and clinical evaluations to market launch.
The MDR regulates that products are assessed based on their intended use, duration of use, location of contact in the body, and invasiveness. The deeper a product is inserted into the body and the longer it remains in the body, the higher the risk. The higher the risk, the more intensive the requirements, especially with regard to the involvement of a Notified Body, Clinical Data, Conformity Assessment, and Post-Market Surveillance.
Medical devices according to the MDR are classified into four main classes:
Class I, IIa, IIb, and Class III
Class I has three subcategories:
Is (sterile), Im (measuring), and Ir (reusable surgical instruments).
In vitro diagnostic medical devices are covered by IVDR (EU) 2017/746, which provides for its own classification system:
Classes A, B, C, and D
In the US, medical devices are approved by the Food and Drug Administration (FDA) on the basis of three risk classes:
Class I, Class II, and Class III
EU classification is based on the classification rules in Annex VIII of the MDR, which set out detailed criteria (see table).
Duration of Use | Place of Application | Reusable Surgical Instrument | Active Medical Device | Use of Biological Material | |||||
< 60 Minutes | < 30 Days | > 30 Days | Degree of | Central Circulatory System / Nervous System | therapeutic | diagnostic | Human | Animal | |
This means that it is not possible to assign medical devices to fixed risk classes across the board; the assignment applies to a specific, individual product.
In addition to the above, the applicant may also consult the relevant state authority or a Notified Body. If the applicant is still unable to classify the medical device, they may submit an application for classification and/or delimitation in accordance with Section 6 (2) MPDG to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) (BfArM).
The intended purpose of a medical device determines its intended use and is therefore directly linked to its risk class. The risk class is highly significant and has a major impact on the manufacturer’s activities, as almost all processes are tailored to it.
The risk class affects the requirements for:
The intended purpose has an often underestimated but central role in the entire MDR process.
Specifically, the intended purpose regulates:
The classification of medical devices in the European Union (EU) and the United States (US) is different not only in terms of terminology, but also in terms of the overall regulatory approach. While the EU follows a rule-based classification system, the US relies on a product- and risk-based comparative assessment.
In the EU risk classification according to the MDR regulations (Annex VIII) is based on criteria such as invasiveness, duration of use and intended purpose. A structured decision path is provided for each product. The assessment and approval are mainly carried out by Notified Bodies.
In the US classification is based on risk and what is known as substantial equivalence, which refers to the similarity to already approved products (predicate devices). The FDA is directly responsible for testing and approval via procedures such as 510(k) or PMA (premarket approval).
| EU MDR | USA FDA | |
|---|---|---|
| Risk Class | Class I, IIa, IIb, III | Class I, II, III |
| Classification | Basis Rule-based according to Annex VIII | Risk- and comparison-based (510(k), PMA) |
| Responsible Authority | Notified body (except Class I) | FDA directly |
Accurate risk classification is essential for achieving fast, cost-efficient and safe approval.
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According to the EU MDR, medical devices are classified into four risk classes: Class I, IIa, IIb and III. This classification is based on the risk posed by the product when used as intended. The higher the class, the stricter the regulatory requirements for approval, clinical evaluation and market surveillance.
The classes represent increasing risk potential:
The requirements for clinical data, technical documentation and the involvement of a notified body increase as the class rises.
The risk classification of medical devices in the EU is based on the classification rules in Annex VIII of the MDR.
Specific criteria for classification are:
In the EU, classification is rule-based according to Annex VIII of the MDR (Class I, IIa, IIb, and III) and relies on Notified Bodies.
In the US, the FDA classifies products into Class I, II, and III based on risk and equivalence to existing products for device approval (510(k) or PMA).
The intended purpose is the foundation of the medical device risk classification. According to the MDR and IVDR, it defines the intended medical benefit, the intended use, the intended patient groups and the intended application. This directly determines the risk class (I, IIa, IIb, III) and the required conformity assessment.
In vitro diagnostic devices (IVDs) are regulated under EU IVDR 2017/746 and classified into four risk-based categories according to their intended purpose and the associated risks to patients and public health:
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
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