MDD 2 MDR

What is MDD?  “MDD” stands for “Medical Device Directive,” and “MDR” stands for “Medical Device Regulation.” In European law, a Directive is a set of guidelines setting minimum standards that can be interpreted by each European Member State.

In Europe Region, there is the MDD (Medical Devices Directive) as well as MDR (Medical Device Regulation). Understanding the MDD vs MDR difference is vital for manufacturers to safely carry out their operations in European countries. 

Getting to know the New CE Mark regulations:

MDR

The MDR is the successor of MDD and has been put in place to protect the health and safety of European Union citizens with special focus on medical devices. The purpose of this new regional standard to ensure that manufacturers produce safe products for Europeans. This includes the medical devices themselves as well as any associated software (MDS). However, one major MDD and MDR difference is where they apply. The MDD applies to medical devices that are used in the European region, and it includes all types of devices as well as software for those devices. This means any device marketed inside Europe is subject to strict MDD regulation standards such as complying with the regulatory requirements or meeting additional requirements. The MDR regulation applies to manufacturers of medical devices that are sold in Europe region.

Steps to transition from the MDD to the MDR

Due to the introduction of MDR regulation, all companies that produce medical products certified with a CE mark according to the MDD directive have to undergo the MDD to MDR transition process to continue to sell their products on the EU market.  

This article discusses the step-by-step process for a smooth MDD to MDR transition that will help avoid possible hiccups and save time and money.   

Until you complete the transition, secure the continuous sale of your Medical devices 

To secure your medical devices sales continuity, you mustn’t lose your certification before the transition period deadline, which is May 2024. To avoid that, you should: 

Be mindful of any changes to your medical devices 

The CE certificate is valid as long as you don’t make any significant changes to the medical product. Any modification to be implemented must be carefully assessed in terms of all risk assessment associated and identified. Also, it must be checked if the intended use of a medical device remains unaffected. If the implemented change impacted either the level of risk or the intended use, then it might result in losing the CE certification. If that happens, the recertification process would follow the MDR requirements.   

related post : ISO 9001 , ISO 14001 ,  ISO 13485 , ISO 27001