Regulatory status, classification, categorisation of products
Frequently asked questions on determining the regulatory status, classification and categorisation of (medical) devices incl. in vitro diagnostic medical devices are answered here.
Reference is made to the following abbreviations:
MDR - Medical Device Regulation - Regulation (EU) 2017/745
IVDR – In vitro Diagnostic Medical Device Regulation - Regulation (EU) 2017/746
MDCG - Medical Devices Coordination Group
MPDG - Medizinprodukterecht-Durchführungsgesetz (EN: Medical Device Law Implementation Act)
What are the risk classes medical devices are divided into?
Medical devices are assigned to risk classes. With the exception of in vitro diagnostic medical devices, medical devices are classified according to the classification rules in Annex VIII MDR. The products are divided into four classes I, IIa, IIb and III, with class III representing the highest risk class.
In vitro diagnostic medical devices are divided into classes A, B, C and D in accordance with Annex VIII IVDR. Class D represents the highest risk class.
I am a manufacturer and do not know whether my product is a medical device. How do I proceed?
The classification of a device as a medical device is determined by the manufacturer with the intended purpose for which the device is intended according to the information on the label, in the instructions for use or in the promotional or sales materials or statements and as specified in its information in the clinical evaluation or its information in the performance evaluation. The person responsible for the classification of a medical device is the manufacturer.
The manufacturer clarifies whether the device is a medical device, an in vitro diagnostic medical device or an accessory to a medical device or in vitro diagnostic medical device on the basis of its intended purpose. The device must fall under the definitions of Article 2 MDR or Article 2 IVDR.
The scope of the MDR also includes products without intended medical purpose that are listed in Annex XVI.
Other sources such as the MDCG documents of the European Commission can be used as reference points for decision-making.
A list of German authorities of the „Länder“ (Landesbehörden) that deal with decisions on the regulatory status, classification and categorisation of medical devices including in vitro diagnostic medical devices can be found under authorities of the „Länder“ classification.
I am a manufacturer of a medical device and do not know in which risk class I should classify my medical device. How do I proceed?
Classification is carried out according to the classification rules of Annex VIII MDR and for in vitro diagnostic medical devices according to the classification rules of Annex VIII IVDR. The intended purpose of the product, which is determined by the manufacturer, is important.
Other sources such as the MDCG documents of the European Commission can be used for decision-making, in particular:
MDCG 2021-24 Guidance on classification of medical devices
Please also refer to the other current documents of the European Commission.
Where can I find information on the regulatory status, classification or categorisation of medical devices?
Other sources can be used for decision-making such as the documents of the European Commission, which you can access at
The following documents, among others, can be used as guidance:
What is meant by "determination of regulatory status"?
The BfArM decides on the regulatory status (formerly "demarcation") of a device as a medical device or accessory to a medical device, or the regularory status of a device as a product listed in Annex XVI of Regulation (EU) 2017/745 upon application in accordance with Section 6 (2) MPDG. The devices shall comply with the definitions in Article 2, number 1 or number 2 (accessories) of the MDR or Article 2, number 1, number 2 or number 4 (accessories) of the IVDR.
The MDR also applies to products without an intended medical purpose that are listed in Annex XVI MDR.
What is meant by a decision on the "categorisation of a product" in class I?
The BfArM decides on the categorisation of a class I device as follows upon application in accordance with § 6 para. 2 MPDG
a) reusable surgical instrument,
b) device that is placed on the market in a sterile condition or
c) device with measuring function.
In which case can an application for determination of the regulatory status, classification or categorisation of a product be submitted in accordance with § 6 para. 1 or 2 MPDG?
In the event of dispute between the manufacturer and its notified body, the manufacturer with a registered place of business in Germany or its notified body are entitled to submit an application in accordance with § 6 para. 1 MPDG.
The authority of the „Land“ (Landesbehörde) responsible for the manufacturer, the manufacturer of the medical device, its European authorised representative or its notified body, based in the territory of Germany are entitled to submit an application in accordance with § 6 para. 2 MPDG.
The intended purpose of the product must be clearly defined by the manufacturer before the application is submitted. At a very early stage in the development of a product, it is not possible to make a final official decision. According to the legal framework, products can only be assessed in their final form, because only then can the intended purpose of a product necessary for a classification decision be reliably assessed.
If any questions arise, the manufacturer should first contact his responsible authority of the Land“ (Landesbehörde) or a notified body.
If this does not lead to clarification, it is possible to submit an application to the BfArM for classification, determination of the regulatory status or categorisation of products in accordance with § 6 para. 1 or para. 2 MPDG. This application must be accompanied by all documents relating to the product that could be helpful in reaching a decision.
In what form can applications for determination of the regulatory status, classification or categorisation of a product be submitted in accordance with § 6 para. 1 or 2 MPDG?
Applications in accordance with § 6 para. 1 and 2 can be submitted informally. This should be done electronically as PDF file(s) by e-mail to mp-klar@bfarm.de . Please note that a document with a signature must be submitted. For general inquiries before submitting an application, please use our contact form.
What documents must be submitted to the BfArM for applications to determine the regulatory status, classification or categorisation of the product in accordance with § 6 para.1 or 2 MPDG?
Formulate your application as an informal, signed application in accordance with § 6 para. 1 or § 6 para. 2 no. 1-3 MPDG and please specify which decision is to be made regarding your product.
To enable a proper decision to be made, please enclose at least the following documents:
- Precise details of the applicant (name, address, contact person, e-mail address of contact person),
- precise details of the manufacturer or, if applicable, his European authorised representative (name, address, contact person, e-mail address of the contact person),
- a written authorisation (power of attorney), if the application is made by a third party on behalf of the manufacturer
- the exact product designation (trade name),
- a reasoned assessment on your part of the classification/categorisation/regulatory status of the product
Intended purpose:
- Instructions for use in German,
- Labeling and packaging,
- promotional or sales materials or statements,
- specifics given in the clinical evaluation or performance evaluation,
- Product description (if applicable, mechanism of action with corresponding evidence),
- further literature, if applicable
- in case of products with active ingredients their exact composition,
- sample or specimen, if applicable.
Please state the reason (previous history) for your application in accordance with § 6 para. 1 or 2 MPDG. Please also indicate if the submitted documents contain confidential information and mark these accordingly.
If an assessment of the product by a third party, e.g. an authority of the „Land“ (Landesbehörde), another authority or a notified body, is already available, this shall be enclosed with the application.
In the case of applications by authorities of the „Länder“ (Landesbehörden) and notified bodies, the manufacturer is given the opportunity to submit written comments during a hearing. The manufacturer receives the application documents for this purpose.
Is an application for determination of regulatory status, classification or categorisation of a product according to § 6 para. 1 or 2 MPDG associated with costs?
Yes, fees are charged for a decision pursuant to § 6 para. 1 or 2 MPDG on the classification, determination of the regulatory status or categorisation of products in accordance with § 1 BGebG in conjunction with § 10 Table 2 No. 1 of the Annex to § 2 (1) BMGBGebV. In case of several products or several decisions per product to be made (decision on regulatory status, classification, categorisation), the fees increase accordingly.
Does the BfArM maintain a list of general classifications of medical devices?
The BfArM does not maintain a list of general classifications, since the examination of each individual product is conducted on a case-by-case basis, taking into account the respective intended use (e.g. instructions for use, advertising materials, product description, labeling, information in the clinical evaluation or performance evaluation, etc.).
Does the BfArM make decisions on a class of similar products?
No, that is not possible. Under the conditions mentioned above, the BfArM can decide on the regulatory status, classification or categorisation of individual specific products only, not on a class of products.
Does a decision by the BfArM also constitute a statement on the marketability of the product?
No, the BfArM is not authorised to do so. In Germany, monitoring the manufacture of, placing on the market and marketing of medical devices (including their operation and use) and the related implementation of the MPDG and its ordinances is the exclusive responsibility of the authorities of the „Länder“ (Landesbehörden) (§ 85 MPDG).
Who may I contact if I have further questions?
Contact information on various topics can be found under FAQ and contact persons.