Classification of Medical Devices under MDR: What You Need to Know
Table of Contents
- What is MDR?
- How Are Medical Devices Classified Under MDR and How to Place Them on the Market?
- Who is a Notified Body?
- What is Post-Market Surveillance (PMS)?
- Conclusion and Recommendations
- Need support with EU MDR 2017/745? We’re here to help.
If you manufacture or sell medical devices in the EU, you must comply with the rules under the European Medical Device Regulation (MDR). This regulation has been in effect since May 2021, and its main goal is to ensure that medical devices are safe, reliable, and properly traceable.
A medical device can be anything from a bandage to an injection needle, a cardiac pacemaker, or medical software. However, each device varies in complexity and how it interacts with the human body, and that’s exactly what determines its classification into one of four risk classes.
What is MDR?
MDR (Medical Device Regulation) is the European Regulation No. 2017/745, which came into effect in 2021. Its goal is to increase the safety and traceability of medical devices on the EU market.
MDR emphasizes:
- Stricter clinical evaluation and post-market surveillance
- Introduction of the UDI (Unique Device Identifier) system
- Mandatory registration of devices and manufacturers in the EUDAMED system
- Thorough classification of devices based on their risk level
How Are Medical Devices Classified Under MDR and How to Place Them on the Market?
Class I – The Lowest-Risk Devices
This category includes basic items that are used on the surface of the body and do not penetrate it.
Examples: bandages, dressings, disposable gloves, dental mirrors, manual wheelchairs
What Must Be Done for Class I Medical Products?
The manufacturer conducts the conformity assessment on their own.
- They must prepare full technical documentation (as required by Annex II and Annex III of the MDR)
- carry out a clinical evaluation
- implement a system for monitoring devices after they are placed on the market (post-market surveillance)
- register the product in the EUDAMED database
- assign a unique device identifier
- affix the CE marking
However, if the device is sterile, includes a measuring function (e.g., thermometer), or is a reusable surgical instrument, a notified body (an independent organization authorized by the EU) must be involved to assess the specific characteristic, such as accuracy of measurement or the ability to sterilize and reuse the device safely.
Subcategories within Class I:
- Is – sterile devices
- Im – devices with a measuring function
- Ir – reusable surgical instruments
Class IIa – Medium Risk
This includes devices that enter the body for a short period or interact with it in a limited way.
Examples: contact lenses, injection needles, ultrasound diagnostic equipment or medical device software with decision support functions.
What Must Be Done for Class IIa Medical Products?
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The manufacturer must work with a notified body, which will review the technical documentation, assess the device’s safety, and evaluate the quality management system of the manufacturer
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The manufacturer also prepares a clinical evaluation, a post-market surveillance plan, assigns a unique device identifier, and registers the product in the EUDAMED database
Class IIb – Higher Risk
These are devices that are used for longer periods or affect vital bodily functions.
Examples: infusion pumps, ventilators, X-ray machines, advanced hospital beds
What Must Be Done for Class IIb Medical Products?
- The involvement of a notified body is mandatory
- The process is more complex and places greater emphasis on safety, technical documentation, and clinical data
- The manufacturer must submit technical documentation to a notified body for review, and upon approval, can proceed with CE marking, EUDAMED registration, and market placement
- A full quality management system is also required
- A clinical study for Class IIb is often required, but it is not automatically mandatory as it is for Class III. Whether a study is needed depends on the type of device, the availability of clinical data, and the ability to demonstrate equivalence
Class III – Highest Risk
This includes devices that are implanted into the body, are life-supporting, or have a direct and significant effect on a patient’s health.
Examples: cardiac pacemakers, artificial heart valves, stents, brain electrodes
What Must Be Done for Class III Medical Products?
This is the most demanding process. The notified body must thoroughly review all aspects of the product – from the technical documentation to clinical data, production methods, and safety.
Placing a Class III device on the market requires:
- Detailed technical documentation - a notified body for thorough review, and only after approval can they proceed with CE marking, EUDAMED registration, and placing the product on the market
- Clinical study: Mandatory. The manufacturer must provide data from their own clinical study demonstrating the device’s safety, effectiveness, and clinical benefit for the patient
- A fully functional quality management system
- An effective post-market surveillance plan
- A plan for post-market clinical follow-up (continued clinical monitoring after the product is on the market)
| Class | Notified Body | Clinical Evaluation | Clinical Study | QMS | Post-market Clinical Follow-up | EUDAMED / UDI / CE |
|---|---|---|---|---|---|---|
| I | ❌ No ✅(exceptions: Is, Im, Ir – only for specific aspect) | ✅ Yes | ❌ No | ❌ No | ⚠️ Basic PMS | ✅ Yes |
| IIa | ✅ Yes | ✅ Yes | ⚠️ Possible | ✅ Yes | ⚠️ Sometimes | ✅ Yes |
| IIb | ✅ Yes | ✅ More in-depth | ✅ Often | ✅ Yes | ✅ Yes | ✅ Yes |
| III | ✅ Yes | ✅ Very detailed | ✅ Almost always | ✅ Yes | ✅ Yes | ✅ Yes |
Who is a Notified Body?
A Notified Body is an independent organization (usually a specialized company or institution) that is officially designated by the European Union to assess whether a medical device complies with all the requirements of the Medical Device Regulation (MDR).
Its role is to review the product’s documentation, safety, manufacturing quality, and, if necessary, clinical data related to the device.
Step-by-Step Process for Approving Medical Software (Class IIa – Heart Rhythm Monitoring App)
What is Post-Market Surveillance (PMS)?
Post-market surveillance is a mandatory process through which the manufacturer monitors the performance, safety, and quality of a medical device after it has been placed on the market and is being used in real-life settings.
The goals of Post-Market Surveillance are:
- Detect potential adverse effects, errors, or malfunctions
- Verify that the device continues to function as intended
- Collect feedback from users (e.g., doctors, patients)
- Support continuous improvement of the product
What Does Post-Market Surveillance (PMS) Mean for Manufacturers?
Every manufacturer of a medical device under the European MDR is required to have a Post-Market Surveillance (PMS) system in place, regardless of the device’s risk class. However, the scope and format of the obligations vary depending on the device’s classification.
Two main documents are used for this purpose:
PMS Report (for Class I)
- An internal document, which does not need to be submitted regularly to a Notified Body
- However, it must be readily available and kept up to date, especially for inspections or audits
PSUR – Periodic Safety Update Report (for Classes IIa, IIb, and III)
- A formal and structured report that must be:
- regularly updated
- submitted to the Notified Body (if one is involved)
- Includes information on safety, performance, PMS outcomes, and any corrective actions taken
Overview of Post-Market Surveillance Obligations by Risk Class
| Class | Type of Report | Frequency |
|---|---|---|
| I | PMS Report | As needed (not strictly defined) |
| IIa | PSUR | At least every 2 years |
| IIb | PSUR | Annually |
| III | PSUR | Annually |
Conclusion and Recommendations
While the MDR introduces stricter requirements, it ultimately helps distinguish high-quality, functional, and safe applications from unverified or commercially questionable solutions. For serious software manufacturers, this is an opportunity to stand out, gain the trust of healthcare professionals and patients, and ensure long-term stability on the market.
The process of approving a medical device under the European MDR regulation is demanding, but essential for ensuring patient safety and building trust in your product. Although it may seem complex, it is clearly structured and provides room for innovation if the manufacturer takes a systematic, quality-driven approach.
If you do not have an internal team for regulatory compliance, working with a qualified consulting firm can significantly accelerate the certification process and reduce the risk of rejection or complications during an audit. Consulting with clinical experts and quality management professionals can help you avoid mistakes that could otherwise cause delays or certification failure.
MDR can be a challenge, but with the right approach and support from experienced partners, it is possible to bring even sophisticated medical software to market efficiently, safely, and with confidence.
Need support with EU MDR 2017/745? We’re here to help.
We’ve helped numerous medical devices successfully reach the market, and we’re ready to support your product too. Our team has collaborated on large-scale regulatory and development projects with international leaders such as Merck, Ypsomed, Novartis, and Dentsply Sirona.
Whether you’re navigating classification, preparing technical documentation, or setting up a compliant QMS, we bring hands-on experience and deep regulatory knowledge to every step of the process.