Navigate the EU Medical Device Regulation for Devices on the European Market
See how the new MDR differs from previous regulations—download the guide > > >
As of 26 May 2021, any device placed on the market in the European Union must be compliant with Medical Device Regulation (EU) 2017/745 (MDR). The MDR replaces the medical device directive (MDD) and active implantable medical device (AIMD) directive.
Similarly, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) is applicable from 26 May 2022. It replaces the in vitro diagnostic directive (IVDD). However, IVDR is not addressed in this guide about the new MDR.
What’s Inside
- How the MDR differs from the previous MDD and AIMD directives, and what the date of application means for devices on the European market.
- How to read Annex VIII device classification rules across non-invasive, invasive, and active devices—plus the special rules.
- The core MDR obligations: vigilance, device registration (including UDI), market surveillance, and post-market surveillance (PMS).
- Guidance on self-certified Class I devices, the requirements of economic operators, and restrictions for legacy devices.
- The role of the Medical Device Coordination Group (MDCG) and how its guidance clarifies the regulation.
What Is the MDR?
The new MDR intends to improve the quality, safety, and reliability of medical devices placed on the European market. It aims to clarify information about medical devices for practitioners and consumers and enhance vigilance and market surveillance.
It covers AIMDs plus a variety of products without an intended medical purpose (for example, decorative contact lenses, liposuction, and hair removal lasers).
Know and adhere to deadlines beyond the date of application—download the guide > > >
Get Familiar with the New Requirements
The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by EU member states. The goal of the MDCG is to help ensure that the MDR (and IVDR) are implemented efficiently and effectively. For companies placing devices on the European market, MDCG guidance documents clarify various aspects of the MDR and IVDR.
Annex VIII of the MDR contains classification rules for devices. It shares definitions that are specific to classification rules; describes how to apply classification rules according to the intended purpose of a device; includes classification rules for non-invasive, invasive, and active devices; and addresses special rules.
Other Activities Addressed in the MDR
- Vigilance. The purpose of the medical device vigilance system is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurring incidents related to the use of a medical device.
- Registration. The obligations to register devices can be found in MDR Article 29 and Article 31. Article 29 requires manufacturers to upload information about each device, including its Unique Device Identification (UDI) information.
- Market surveillance. MDR Articles 93 through 100 are primarily concerned with activities of the Commission, Member States, and competent authorities. Manufacturers must be prepared to cooperate and provide information as needed.
- Post-market surveillance (PMS). The benefits of a device must continue to outweigh the risks. This is accomplished by proactively monitoring information from various sources.
There’s more! Get the guide for information about self-certified Class I devices, requirements of economic operators, and restrictions for legacy devices > > >
The MDR touches nearly every part of a device organization—quality, regulatory, engineering, and the systems that hold your device data. The same expectations that make regulators ask for traceable, well-controlled records also depend on validated systems and trustworthy data. Treating MDR readiness as an ongoing program rather than a one-time deadline event is what keeps devices on the European market without surprises. USDM Life Sciences helps life sciences companies connect regulatory requirements to the underlying systems, processes, and data integrity practices that make compliance durable.
EU MDR Readiness FAQ
When did the EU MDR become applicable?
As of 26 May 2021, any device placed on the market in the European Union must be compliant with Medical Device Regulation (EU) 2017/745 (MDR). The MDR replaces the medical device directive (MDD) and the active implantable medical device (AIMD) directive.
What is the difference between the MDR and the IVDR?
The MDR, Regulation (EU) 2017/745, governs medical devices and applies from 26 May 2021. The IVDR, Regulation (EU) 2017/746, governs in vitro diagnostic medical devices and is applicable from 26 May 2022, replacing the in vitro diagnostic directive (IVDD). This guide focuses on the MDR and does not address the IVDR.
How are devices classified under the MDR?
Annex VIII of the MDR contains the classification rules. It defines terms specific to classification, describes how to apply the rules according to a device’s intended purpose, and provides classification rules for non-invasive, invasive, and active devices, along with special rules.
What is the role of the MDCG?
The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by EU member states. It helps ensure the MDR and IVDR are implemented efficiently and effectively, and its guidance documents clarify various aspects of both regulations for companies placing devices on the European market.
What obligations does the MDR place on device registration?
The obligations to register devices appear in MDR Article 29 and Article 31. Article 29 requires manufacturers to upload information about each device, including its Unique Device Identification (UDI) information.
MDR compliance rarely stays inside one team. Vigilance, registration, and post-market surveillance all generate records that must be controlled and trustworthy, which ties device readiness to broader programs such as electronic records and signatures controls, a risk-based assurance approach for the systems that support these processes, and continuous compliance for the cloud platforms that hold regulated data.
Build a Repeatable MDR Compliance Program
Every part of your organization is responsible for MDR compliance, but it doesn’t have to be overwhelming. Let USDM Life Sciences help you understand and implement the necessary changes. Contact us for up-to-date information and to learn about training to help everyone in every role gain the necessary knowledge to achieve and maintain compliance.
Ready to dig in? Download the EU MDR Date of Application Readiness Guide above, or contact us to talk through your MDR readiness.