February 22, 2018

MDR vs. MDD: 13 Key Changes

Medical Device Regulation (MDR) vs. Medical Device Directive (MDD)Europe's new Medical Devices Regulation (MDR) will bring significant regulatory changes that may impact multiple business units within your organization.

As companies begin planning their transition program to bring their organizations into compliance under the new Regulation, it's important to be aware of all the major changes that will require planning and action.

The video below is a snippet from our recent free webinar, The Complete Guide to EU-MDR Transition. In the full webinar, we highlight the key parts of the MDR, while going a step further to present a step-by-step MDR transition process that can be adapted to suit your company's unique needs.

Click here to watch the full presentation.

In the snippet below, Larry Stevens, RAC, offers a look into 13 important changes between the current Medical Device Directive (MDD) and the MDR. We've highlighted these 13 points in text below as well.

13 Key Changes in the EU-MDR

  • The new regulation is four times longer, and contains five more annexes than its predecessor, the Medical Device Directive (MDD).

  • The word "safety" appears 290 times in the MDR. The MDD, by comparison, uses it only 40 times.

  • Significant changes in wording used in the new law will require companies to rationalize their portfolios and perform a global impact assessment in order to implement the necessary changes to remain compliant.

  • Annex I, General Safety and Performance Requirements, identifies new conditions that will need to be addressed for most legacy devices (CE marked under the MDD). Existing products must be recertified in accordance with the new regulations.

  • The new rules will require most companies to update clinical data, technical documentation, and labeling.

  • Unique Device Identification (UDI) will be implemented to help track devices throughout the economic operator supply chain and will be required on all labels.

  • While the scope of the MDD did not encompass medical purpose devices and AIMD, these are both included under MDR.

  • The definition of medical device will be broadened to include non-medical and cosmetic devices not previously regulated. Examples include products for cleaning, disinfection or sterilization of devices as well as contact lenses, liposuction equipment, or epilation lasers.

  • Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims including tighter equivalency standards.

  • Manufacturers will need to report all incidents, injuries and deaths into an EU portal that will centralize relevant data so that patients have access to more safety-related information. Reporting for incidents that did not result in death or serious deterioration in health is moved to 15 days from 30 days.

  • Companies undergoing transition will need to revisit core processes including the quality assurance, risk management, and postmarket expectations. These will require careful review, planning and updating to re-implement in compliance with new requirements.

  • Reclassification of many medical devices to a higher risk class and a new classification for reusable surgical devices requiring notified body oversight.

  • IVDs are now classified into four risk classes that will require notified body review for about 90% of the devices, up from the current 10%.

Watch our free webinar to learn more about the MDR and how to prepare for successful transition 


Topics: MDR, Medical Devices, Global Regulations