A key moment in the compliance process of products is their classification. It is the manufacturer’s sole responsibility to select the appropriate class and rule of their medical device, depending on the device’s intended purpose and inherent risk. This step is essential, as it defines the conformity assessment manufacturers must follow, such as involving a notified body for higher-risk devices, among other obligations.
In our MDlaw Library, we have collected all relevant documents that could help you classify a device for the EU market under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
Article 2(1) and Article 1 of EU MDR & IVDR
For EU Regulation on medical devices/IVDs to apply to a product, it is essential to verify that the product falls under the definition of a medical device or IVD defined in Article 2(1), and that it is included in the scope of the Regulation (Article 1).
Article 51 of EU MDR & Article 47 of EU IVDR
The two most relevant classification articles of EU Regulations on medical devices and IVDs are MDR Article 51, which divides medical devices into classes I, IIa, IIb and III, and IVDR Article 47 which envisages 4 IVD classes: A, B, C and D.
Only MDR Class I (except for Class Is, Im, Ir) and IVDR Class A (except for Class A sterile) do not need to involve a notified body.
The above two MDR and IVDR articles also prescribe that the classification of medical devices shall be defined in accordance with Annex VIII.
Annex VIII of EU MDR & IVDR
Annexes are part of EU Regulations on medical devices and IVDs and are consequently legally binding. Annex XVIII contains definitions related to the duration of use, invasiveness of devices, active devices, 22 classification rules and implementing rules. An example of an implementing rule would be that in case several rules apply to a device in view of its intended purpose, the strictest or highest risk class prevails.
Commission Implementing Regulation (EU) 2022/2347
The European Commission has adopted a legally binding Regulation to reclassify certain active products without intended medical purpose (Annex XVI):
- high intensity electromagnetic radiation emitting equipment as referred to in Section 5 of Annex XVI to Regulation (EU) 2017/745 that is intended for the use on the human body for skin treatment is reclassified as class IIb, unless it is intended for hair removal only in which case it is reclassified as class IIa;
- equipment intended to be used to reduce, remove or destroy adipose tissue as referred to in Section 4 of Annex XVI to Regulation (EU) 2017/745, is reclassified as class IIb;
- equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain as referred to in Section 6 of Annex XVI to Regulation (EU) 2017/745 is reclassified as class III.
In addition to the regulations, manufacturers have a large number of guidance documents which can assist them in the classification. The following guidance documents are not legally binding. However, they contain opinions and interpretations of the national authorities of all EU Member States that are part of the MDCG or specific sub-groups on classification. When classifying products, we advise consulting them. Especially MDCG 2021-24 and 2020-16 should be read together with EU MDR and IVDR, as these guidance documents were developed to ensure uniform application of the legal provisions. As a general remark, only the Court of Justice of the EU can provide final and binding interpretations of EU law.
MDCG Guidance on classification of medical devices (MDCG 2021–24) and IVDs (MDCG 2020-16)
These almost 60-page documents are essential in supporting manufacturers when uncertain on the correct risk class of the device. They contain definitions, graphical summaries, and general explanation of rules with practical issues and examples.
Guidance document on Qualification and Classification of Software (MDCG 2019-11)
MDCG 2019-11 defines the criteria for the qualification of software, and includes definitions, examples, and helpful flowcharts. It is worth mentioning the European Commission Factsheet: Is your software a medical device? that assists with classification in a more schematic and simplified way.
Guidance on borderline between medical devices and medicinal products
MDCG 2022-5 aims at further clarifying how to classify products, where it is not clear whether they fall under the EU MDR or MPD (Directive 2001/83/EC on the Community code relating to medicinal products for human use). It includes definitions of pharmacological, immunological, metabolic means, medical diagnosis. In addition, it provides some examples of medical devices, medicines, herbal medicinal products, substance-based devices intended to be introduced into the human body or applied to the skin, etc.
Manual on Borderline and Classification
Some of the new examples of borderline products from the autumn 2023 revision of the Manual are:
- Root canal irrigation solution
- n-butyl-2-cyanoacrylate based adhesives
- System intended to produce sclerosing foam
- Temperature sensors embedded in orthopaedic devices for compliance tracking
- Custom-made cranial implant
In case you need further advice, Obelis Group consultants can further support you.