What is the Medical Device Regulation?

What Is the Medical Device Regulation (MDR)?

The Medical Device Regulation (MDR) is the regulation that medical device manufacturers must adhere to in order to bring their devices to the European Union (EU). It was adopted in April 2017 and became applicable in May 2021 where it changed the legal framework for medical devices by replacing the Medical Device Directive (MDD) to enhance medical device effectiveness and patient safety. The MDR provides new responsibilities for the European Medicines Agency (EMA) and other competent authorities when assessing medical devices. These pertain to medicines with an integral device, ancillary medicinal substance, devices from substances that are absorbed by the human body, and borderline products that are associated with uncertainty with respect to which regulatory framework applies to them.

Key Changes in the Medical Device Regulation(MDR)

The smooth implementation of the MDR has been supported by the collaboration between key stakeholders. This includes EMA, the European Commission (EC), competent authorities, notified bodies, and other important collaborators from the medical device and pharmaceutical industry. Updated guidance documents related to quality requirements for devices and updated ‘Question and Answer’ documents.

Overall, the Medical Device Regulation (MDR) is more comprehensive than the MDD as it includes a wider scope to cover active implantable medical devices and those devices that have components of non-viable human tissues/cells. Furthermore, the MDR also provides detailed information that should be included in the declaration of conformity, how to keep it updated and available in all languages for which the device is distributed in the Member States.

With respect to post-market safety surveillance, the MDR specifies requirements for post market surveillance (PMS) system as a part of the device manufacturer’s quality management system (QMS), included the use for all gathered and relevant data. For example, the requirements for a PMS plan and post-market clinical follow up (PMCF) are outlined in detail. In contrast, the MDD included the need to conduct PMS and PMCF but did not define the detailed requirements.

DDReg’s Capabilities

As part of its diverse portfolio, DDReg has provided its customers with support for medical device registration for their target markets including but not limited to:

Support in regulatory intelligence for medical device strategy and subsequent registration.

Advisory services for medical device classification.

Establishing a quality management system.

Local support for medical device registration.

Medical regulatory and safety writing for devices.

Expertise in drug-device and combination products.