- Regulation (EU) 2017/745 divides medical devices into four classes, I, IIa, IIb and III, according to their intended purpose and their risk.
- The 22 rules of Annex VIII determine the class; when several apply, the strictest one prevails.
- Regulation (EU) 2023/607 allows devices certified under the Directives to be placed on the market until December 31, 2027, or 2028, depending on their class.
- Four EUDAMED modules have been mandatory since May 28, 2026; the clinical investigations module is not online (European Commission, 2026).
Understand the classification.
Medical devices are classified into different categories according to their level of risk to patients. The criteria for classification differ from country to country, but in general, they take into account the duration and nature of the device’s interaction with the human body, as well as the level of control needed to ensure the device’s safety and effectiveness.
In Europe, medical device classes are defined by Regulation (EU) 2017/745 (EU MDR), which repealed Directive 93/42/EEC. Its Article 51 divides devices into four classes, I, IIa, IIb and III, according to their intended purpose and inherent risks. Below are the main medical device classes, based on the level of risk they present:
| Class | Risk | Device examples | Key requirements |
|---|---|---|---|
| I | Low | Bandages, eyeglasses, stethoscopes, compression stockings | Self-declaration of conformity, CE marking, technical documentation |
| IIa | Medium | Hearing aids, dental crowns, short-term internal use devices | Notified body assessment, quality system audit |
| IIb | High | Incubators, ventilators, dialysis machines, defibrillators | Notified body audit, in-depth clinical evaluation |
| III | Very high | Pacemakers, breast implants, hip prostheses, heart valves | Notified body assessment, clinical investigations required in principle, reinforced post-market surveillance (PMS/PMCF), expert panel opinion for implantable devices |
Regulation (EU) 2017/745 was published in 2017 and has applied since May 26, 2021, after a one-year postponement due to the COVID-19 pandemic. Regulation (EU) 2023/607 extended the transition period for devices still certified under the Directives until December 31, 2027, or December 31, 2028, depending on their class.
This review was undertaken for several reasons:
- Harmonization: The 1993 EU Medical Devices Directive allowed EU Member States to transpose the rules into their national laws, which created differences in the conformity assessment requirements for medical devices. The new regulation harmonizes the requirements across the EU to improve patient safety and ensure a uniformly high level of protection in all member states.
- Strengthened regulation: The new regulation strengthens the regulation of medical devices to ensure increased market surveillance and better transparency for patients and health professionals. It also introduces stricter rules on conformity assessment and certification of medical devices.
- Meeting technological developments: Technological advances have led to the emergence of new types of medical devices, such as mobile health applications, artificial intelligence devices, etc. The new Regulation is designed to address these developments and ensure that new medical devices meet safety and efficacy standards.
In short, the recast of the medical device classes has been undertaken to improve patient safety and ensure a uniformly high level of protection in all EU member states. It also responds to technological developments and strengthens the regulation of medical devices.
In the United States?
In the United States, the Food and Drug Administration (FDA) classifies medical devices into three main categories:
- Class I: least-risk medical devices, such as bandages, eyeglasses, thermometers, etc.
- Class II: moderate-risk medical devices, such as catheters, contact lenses, hearing aids, etc.
- Class III: highest-risk medical devices, such as pacemakers, cochlear implants, hip replacements, etc.
Other countries may have similar classifications, but with different nuances.
For the FDA, the class also determines the submission required before marketing: a 510(k) premarket notification for non-exempt Class I or II devices, a premarket approval (PMA) application for Class III.
Whatever the framework, capturing accurate clinical evidence relies on EDC for medical devices built around classification-specific requirements.
How do you determine the class of your device?
You determine the class by applying the 22 rules of Annex VIII of Regulation (EU) 2017/745 to the intended purpose you claim for the device. These rules fall into four groups. When several rules apply to the same device, Annex VIII applies the strictest one, and the device takes the highest class.
The table shows, for each group of rules, what it covers and an example of a device it places in a high class.
| Group | Rules | What it covers | High-class example |
|---|---|---|---|
| Non-invasive devices | 1 to 4 | Devices that do not penetrate the body, class I by default | Device for channeling or storing blood for eventual infusion: class IIa (rule 2) |
| Invasive devices | 5 to 8 | Devices related to body orifices, surgically invasive devices and implantable devices | Total or partial joint replacement: class III (rule 8) |
| Active devices | 9 to 13 | Devices that depend on a source of energy, software included | Software whose information drives a decision that may cause death or an irreversible deterioration of a person’s state of health: class III (rule 11) |
| Special rules | 14 to 22 | Special cases, including devices that incorporate a medicinal product | Automated external defibrillator: class III (rule 22) |
Class I does not always rule out a notified body. Article 52 of the regulation requires one for a class I device placed on the market in sterile condition, with a measuring function or that is a reusable surgical instrument, for those aspects only.
The class also sets the clinical burden. Article 61 requires clinical investigations for implantable and class III devices, unless the manufacturer demonstrates equivalence with a device it already markets. Our article ISO 14155:2026: What Changes for Your Clinical Investigations details what the standard requires of the protocol. After the device is on the market, the class determines the surveillance report: a post-market surveillance report for class I (Article 85), a periodic safety update report (PSUR) for classes IIa, IIb and III (Article 86).
What changes in 2026 for MDR classification?
In 2026, the classification rules of Annex VIII are those of the 2017 text. Two deadlines do affect your schedule: the end of the transition for devices certified under the Directives, on December 31, 2027, or December 31, 2028, depending on the class, and the mandatory use of four EUDAMED modules since May 28, 2026.
The table lists the dates set by Regulation (EU) 2023/607 until which a device can still be placed on the market without an MDR certificate.
| Device | Can be placed on the market until |
|---|---|
| Class III, and implantable class IIb (excluding sutures, staples, screws, plates, dental crowns and other listed exceptions), with a certificate issued under the Directives | December 31, 2027 |
| Other class IIb, class IIa, class I sterile or with a measuring function, with a certificate issued under the Directives | December 31, 2028 |
| Device self-declared under Directive 93/42/EEC before May 26, 2021, that requires a notified body under the MDR | December 31, 2028 |
This extension remains subject to conditions. Among them, the manufacturer had to lodge a formal application for conformity assessment with a notified body no later than May 26, 2024, and sign a written agreement with it no later than September 26, 2024.
Since May 28, 2026, the European Commission has made four EUDAMED modules mandatory: actor registration, UDI and device registration, notified bodies and certificates, market surveillance. The clinical investigations and performance studies module is not yet online: the Commission describes it as under development.
On December 16, 2025, the Commission proposed a targeted revision of the MDR and the IVDR, COM(2025) 1023. The text adapts some Annex VIII rules and would place reusable surgical instruments, accessories for active implantable devices and software in lower classes. As of October 20, 2026, the competent committee of the European Parliament has not yet voted, and the Legislative Observatory indicates a first-reading plenary sitting on December 14, 2026 (indicative date). Classify your devices according to the Annex VIII currently in force, and review the class of your software when the final text is published.
For the clinical follow-up that starts after CE marking, our article PMCF: Understanding Post-Market Clinical Follow-Up for Medical Devices explains how to choose the collection method according to the class and clinical history of the device.
[[faq]]
Sources
- European Parliament and Council, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (EUR-Lex), 2017
- European Parliament and Council, Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (EUR-Lex), 2023
- European Commission, Overview, EUDAMED page of DG SANTE (health.ec.europa.eu), 2026
- European Commission, Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 […], COM(2025) 1023 final (EUR-Lex), 2025
- European Parliament, Procedure File: 2025/0404(COD), Legislative Observatory (oeil.europarl.europa.eu), 2026
- FDA, Classify Your Medical Device (fda.gov), 2026
How many medical device classes does the MDR define?
Regulation (EU) 2017/745 defines four classes: I, IIa, IIb and III, in order of increasing risk. Its Article 51 classifies each device according to its intended purpose and inherent risks, and Annex VIII sets the 22 rules used to determine the class.
Which class does medical device software fall into?
Rule 11 of Annex VIII places software that provides information used to take diagnostic or therapeutic decisions in class IIa. It moves to class IIb if the decision may cause a serious deterioration of a person’s state of health, and to class III if it may cause death or an irreversible deterioration. All other software falls into class I.
Until when can a device certified under Directive 93/42/EEC be placed on the market?
Regulation (EU) 2023/607 sets December 31, 2027, for class III and implantable class IIb devices, and December 31, 2028, for other class IIb, class IIa and sterile or measuring class I devices. The manufacturer had to file its application with a notified body before May 26, 2024.
Does the MDR revision proposed in 2025 change the class of my device?
Not at this stage. Proposal COM(2025) 1023 of December 16, 2025 would place some software, reusable surgical instruments and accessories for active implantable devices in lower classes. As of October 20, 2026, the European Parliament has not voted on it: the Annex VIII currently in force remains the reference.
Florentin combines clinical research know-how with a true passion for product design. Attentive to detail and obsessed with user experience, he ensures that Datacapt remains a high-performance platform that’s also intuitive and accessible to every user.
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