Risk Class & Medical Device Classification in the EU

Before products can be sold or used, they must meet the legal requirements and procedures of the respective jurisdiction (e.g. Pharmaceutical, Cosmetic, Medical Device) in order for them to comply with applicable standards and regulations. If the product is a Medical Device according to Article 2 No.1 Regulation (EU) 2017/745 about Medical Devices (Medical Device Regulation, MDR), it is necessary to prove the compliance of the Medical Devices with the essential requirements of the MDR in a conformity assessment procedure. This is done depending on the Risk Class to which the Medical Device is assigned.

In-Vitro Diagnostics (IVD) are divided into classes A, B, C and D.
For Medical Devices according to MDR, except IVD, the classification into Risk Class I with the respective subclasses (sterile products of class I (Is), Class I products with measuring function (Im), Class Ir for reusable surgical instruments) Class IIa, IIb and III.
For the US approval, the Food and Drug Administration divides the products, according to the product types listed, into Classes I, II, III.

The classification, which is based on the vulnerability of the human body, takes into account the intended purpose of the product and the risks associated with it. As a rule, the longer the product is used and the deeper the product is introduced into the body, the higher the risk and therefore the classification. The classification is based on the classification rules in Annex VIII of the MDR with 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
Invasivity

Central Circulatory System / Nervous System

therapeutic

diagnostic

Human

Animal

In this context, it is not possible to make a general assignment of Medical Devices to fixed Risk Classes; the assignment applies to the specific, individual product.

Applicants who have problems with the classification can, after reviewing all the available literature on the subject, first contact their responsible State Authority or a Notified Body and finally apply to the Federal Institute for Drugs and Medical Devices for Classification and/or demarcation in accordance with Section 6 (2) MPDG.

Definition of Risk Classes and Intended Purpose

From the Risk Class and the Intended Purpose, the effort for further approval also depends. With increasing Risk Class, the requirements also increase, so for example, the involvement of a Notified Body may be required.

Risk Class and Intended Purpose also form the basis of the technical documentation, can be found in important documents and should be determined with extreme care.

The Risk Class is highly significant and has a major influence on the activities of the manufacturer, since almost all processes are aligned with it. These include, for example:

The Quality Management System and a Post-Market-Surveillance System must be appropriate for the Risk Class.
Determined by Notified Bodies as part of the Conformity Assessment Procedure, e.g. unannounced on-site audits and sample testing.
Is Part of the Technical Documentation, EU Declaration of Conformity, UDI Database
The scope of testing in product testing

Intended Purpose of a Medical Device

The significance of the Intended Purpose for the overall procedure is generally underestimated and is not always easy to understand. Specifically, the Intended Purpose regulates:

the legal area in which the product is to be classified (Cosmetic, Biocide, Pharmaceutical, Medical Device)
defines requirements for performance/clinical performance, compatibility and the extent of clinical evidence, and is therefore the basis for the “Risk-Benefit-Analysis”
placing on the market and commissioning must comply with the MDR for the Intended Purpose
products must be suitable for their Intended Purpose under normal conditions of use.
determines the extent of the general safety and performance requirements, requirements for design and manufacturing
is part of the Instructions for Use, the Summary of Safety and Clinical Performance, the Technical Documentation (Product Description and Specification)

We are happy to assist you with the classification of your Medical Device. Contact us to arrange a meeting.