Learn how to navigate the medical device regulation for devices that are placed 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 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 include:
- 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 > > >
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.
