New Whitepaper: Product Classification according to MDR and IVDR

Manufacturing companies are tasked with evaluating risk classes for medical devices and in-vitro diagnostics in compliance with MDR and IVDR stipulations. Both MDR (EU Regulation 2017/745) and IVDR (EU Regulation 2017/746) employ four classification classes, increasing in risk.

Raising the key question: What risk class suits your medical product? Prior to tackling this query, it’s imperative to consult regulations for verifying the product’s classification as a medical device.

For a thorough understanding, exploring our new whitepaper comes highly recommended.

Classification of Medical products

The categorization is carried out into the four ascending risk classes I, IIa, IIb, and III (from low to high risk). Additionally, for Class I products, a distinction based on sterile use (Is) or the presence of a measuring function (Im) is necessary. In the context of the IVDR, there are also four classes with increasing risk – Class A, Class B, Class C, and Class D – to which the categorization is applied.

By the way: Standalone software, which refers to medical software not used as control software for a medical device (such as Medical Apps), is also considered an active medical device according to MDR and BfArM. Therefore, the determination of intended use and risk classification falls under the responsibility of the manufacturers and may be done after consultation with the Notified Body if needed.

22 Classification rules according to MDR

The accurate classification into the appropriate risk class depends on the intended use of the medical device. To determine this, manufacturers must meet the definition for medical devices as outlined in Article 2 of the MDR.

Once manufacturers have established the intended purposes, the EU Regulation specifies a total of 22 rules in Annex VIII that apply to the subsequent process. Distinctions are made between rules for invasive and active products, as well as specific provisions for different types of products.

A general assignment to risk classes is not possible across the board, according to the Federal Institute for Drugs and Medical Devices (BfArM).

7 Classification rules according to the IVDR

Similar to the Medical Device Regulation (MDR), the classification of products under the In-Vitro Diagnostic Regulation (IVDR) is based on the intended use and the associated risk profile. For this purpose, seven classification rules have been established.

Only for medical devices in Class A, manufacturers have the option to independently assert compliance. For other risk classes, involving a Notified Body in the conformity assessment process is necessary.

In the field of in-vitro diagnostics as well, manufacturers cannot make a general classification universally.

Everything at a Glance: Our New Whitepaper

The topic of product classification often accompanies you in your daily work, and you’re in search of an overview that summarizes the essentials? Fantastic! Why not download our new whitepaper and delve into more about risk classification according to MDR and IVDR.

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New Whitepaper: Product Classification according to MDR and IVDR

Classification of Medical products

Everything at a Glance: Our New Whitepaper

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