We handle qualification and classification under the MDR and IVDR: medical device, IVD, medicinal product or cosmetic, and which class Annex VIII produces. Both follow from the intended purpose that the manufacturer defines and justifies in the technical documentation.
Overview
Qualification and classification for medical devices and IVD · MDR Art. 1, 2, 4, 51 and Annex VIII · IVDR Art. 1, 2, 3, 47 and Annex VIII · MDCG 2021-24, 2020-16, 2019-11
Last updated: October 30, 2026
The manufacturer determines the status and class of a product. It justifies both in the technical documentation (Annex II Section 1.1(e) and (f) of the MDR and IVDR), and the notified body verifies them before issuing a quotation and when the application arrives (Annex VII Sections 4.2 and 4.3).
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Services
Assessment of whether the product meets the definition of a medical device (Art. 2(1) MDR), an IVD (Art. 2(2) IVDR), an accessory or an Annex XVI product, or falls under an exclusion in Art. 1(6) MDR such as medicinal products, cosmetics or food, and for laboratory products under Art. 1(3) IVDR. Deliverable: a qualification with references, as Annex II Section 1.1(e) requires.
A walk through the implementing rules and every rule the intended purpose touches: 22 rules of the MDR with classes I, IIa, IIb and III, seven rules of the IVDR with classes A to D. Deliverable: the class with the justification for each rule applied, as Annex II Section 1.1(f) requires, and the rules that were checked and discarded.
Devices incorporating a substance that would be a medicinal product if used separately (Art. 1(8) MDR, Rule 14), devices intended to administer medicinal products (Art. 1(9) MDR), substance-based devices (Rule 21), devices incorporating an IVD (Art. 1(7) MDR, Art. 1(4) IVDR) and accessories classified in their own right. Checked against the Manual on borderline and classification and MDCG 2022-5 Rev. 1.
How we work together
Whether a product is a medical device is decided by the definition in Art. 2(1) MDR: a medical purpose defined by the manufacturer, and a principal intended action that is not achieved by pharmacological, immunological or metabolic means. An IVD is a medical device that examines specimens derived from the human body in vitro and has one of the purposes listed in Art. 2(2) IVDR.
Art. 1(6) MDR draws the outer boundaries. Medicinal products, advanced therapy medicinal products, cosmetic products under Regulation (EC) No 1223/2009 and food are outside the MDR. For devices incorporating a medicinal substance or intended to administer medicinal products, Art. 1(8) and (9) set out which rules apply. If a product, taking into account all its characteristics, may be both a medicinal product and another product, medicinal product law takes precedence (Art. 2(2) Directive 2001/83/EC).
| MDR | IVDR | |
|---|---|---|
| Classes | I, IIa, IIb, III (Art. 51) | A, B, C, D (Art. 47) |
| Rules in Annex VIII | 22, with implementing rules in Chapter II | 7, with implementing rules in Section 1 |
| Several rules apply | strictest rule and sub-rule (Section 3.5) | rule resulting in the higher class (Section 1.9) |
| Software | class of the device it drives, or standalone, Rule 11 (Section 3.3) | class of the device it drives, or standalone (Section 1.4) |
| Dispute with the notified body | competent authority where the manufacturer is registered (Art. 51(2)) | competent authority where the manufacturer is registered (Art. 47(2)) |
| MDCG guidance | MDCG 2021-24 Rev. 1, April 2026 | MDCG 2020-16 Rev. 5, September 2026 |
The class drives the conformity assessment route and thereby whether, and to what extent, a notified body is involved. That is why the MDR and IVDR require qualification and class to be justified in the technical documentation, and why the notified body checks both before it issues a quotation.
For borderline cases there are two sources outside the regulations: the MDCG guidance and the Manual on borderline and classification, in which the competent authorities record individual cases. Neither is binding. A classification only becomes binding through a Commission implementing act (Art. 4 and 51(3) MDR, Art. 3 and 47(3) IVDR) or a decision of the competent authority.
Outside the scope of this page are the route from the class to CE marking with the choice of conformity assessment procedure, the development of software to IEC 62304, IVDR implementation for a whole portfolio, and the choice of pathway at the FDA.
Our approach
Step
Result
Define the intended purpose
An intended purpose that sets user, patient population, place of use and duration precisely enough to derive qualification and class from it.
Qualify
A reasoned qualification as medical device, IVD, accessory, Annex XVI product or product outside the MDR and IVDR, with the boundaries checked.
Classify
The class under Annex VIII with every rule applied and the implementing rules that determine it.
Align
A justification in the technical documentation that the notified body can follow in its application review, and open borderline questions with their reference in the Manual or the MDCG guidance.
Common pitfalls
The class from the time of Directive 93/42/EEC is carried over.
Its Annex IX had 18 rules, Annex VIII of the MDR has 22; Rules 19 to 22 are new (nanomaterials, inhalation of medicinal products, substance-based devices, active therapeutic devices with a diagnostic function), and Rule 11 now covers software, whereas in the Directive it governed active devices for administering substances (now Rule 12).
An accessory is given the class of the device it is used with.
The MDR and IVDR require accessories to be classified in their own right (MDR Annex VIII Section 3.2, IVDR Section 1.3). Under the IVDR, calibrators and control materials with assigned values are the exception: they take the class of the device (Sections 1.5 and 1.6).
A laboratory product is labeled Research Use Only and offered for diagnostic purposes at the same time.
The IVDR does not apply to research use only products unless the manufacturer specifically intends them for in vitro diagnostic examination (Art. 1(3)(a) IVDR); under MDCG 2024-11 such a product cannot have a medical purpose.
The intended purpose in the instructions for use is broader than the one the classification rests on.
Every intended purpose the manufacturer states counts for the class; with several, the higher class applies (IVDR Annex VIII Section 1.8, MDR Section 3.5).
Product Development & Regulatory Strategy
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
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IVDR implementation for a whole IVD portfolio, from classification to certification
Software as a Medical Device →
Development to IEC 62304, cybersecurity and approval of software as a medical device
FDA Strategy & Pathways →
Pathway choice between 510(k), De Novo and PMA for the US market
Notified Body Selection & Interaction →
The procedure with the notified body in which the classification is verified
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