Device Qualification & Classification


Device Qualification & Classification


Most (if not all) regulatory frameworks around the world define specific requirements and conformity assessment procedures dependent on the medical device and the risk it poses to the patient or end user. Based on this risk, a device will fall under a particular risk category, also known as a risk classification/class.

However, before a product can be fit under a particular classification, it must first qualify as a medical device (or IVD) against the relevant legislation within a particular jurisdiction. This in itself may be a difficult task, especially for borderline products.

The qualification of your product as a device and the subsequent classification will depend on its intended purpose and mode of action and will have a major impact on the regulatory pathway you must follow.

Specifically for EU legacy devices, you may be required to have a detailed classification rationale under the EU Regulations in order to justify the use of EU MDR Article 120 or EU IVDR Article 110 transitional provisions.

Needless to say, this is a critical step. Therefore, it is vitally important to get this done correctly in order to avoid wasting both time and money.


We provide a detailed Qualification and Classification Report for your devices which provides a robust rationale as to why your product qualifies as a medical device and clearly determines the risk classification under the:

  • EU MDR 2017/745.
  • EU IVDR 2017/746.
  • UK MDR 2002.

The report can then be used to identify the specific requirements that your organisation and device will need to meet. If applicable, the report can also be used to gauge or prove your eligibility as a legacy device under Article 120 or Article 110 for the EU MDR and IVDR, respectively.

Specculo Process

Following an initial consultation, our team will ask for a description of the device’s intended purpose and mode of action / operation, including:

  • Device description.
  • Intended use statement.
  • Indications and claims.
  • Description of how the product will function.
  • Instructions for Use.

The assigned consultant will then put together the Qualification and Classification Report, detailing why the product qualifies as a medical device or IVD in accordance with the relevant regulation. The report will then go into detail as to which classification rule will apply, and why the others do not.

The report can then be used:

  • Within your technical documentation.
  • For regulatory approval with competent authorities.
  • To determine your regulatory strategy.

What you get with Specculo

We have years of experience in handling large and small projects alike on a vast range of medical devices and IVD technology.


As your regulatory consultant, you get our full attention throughout the project.


You can expect high quality, state of the art technical documentation.​

Fast lead times

We give you our time and take you through the created documentation, and how to maintain it.​

Simplify your compliance workflow.