Understanding the Differences Between MDD vs MDR: The European Regulation
There are many regulations in place that govern how medical device manufacturers can produce and supply their products. The EU has a few different regulatory requirements for medical devices. In Europe, 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. The MDR is the successor of MDD and has been put in place to protect the health and safety of European Union citizens.
The purpose of this new regulation is to ensure that manufacturers produce safe products for Europeans. This includes the devices themselves as well as any medical device 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 Union, 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 applies to manufacturers of medical devices that are sold in Europe.
This article will explore the difference between MDD and MDR, provide you with an overview of what it entails, and discuss how compliance can help your business to safely do business in Europe.
What is the EU Medical Device Regulation (MDR)?
The Medical Device Regulation (MDR) was established in 2007 and then revised for the first time in 2017. It is the successor of MDD and applies to manufacturers of medical devices sold or exported into Europe, excluding products used inside the EU but may include those marketed outside it. The MDR defines what exactly needs to be done by medical device manufacturers in order to comply with the regulatory requirements. It includes a few different requirements for medical devices and also requires all products to have CE marking on them.
The MDR applies to any type of medical device, including software that is used by those devices (MDS). Some other types of regulations may only be applicable to specific groups or industries – such as the MDD, which applies to devices used inside the EU.
The MDR is a regulation that manufacturers need to comply with in order to sell their products within Europe safely and without any legal risk. It’s also important for these companies’ compliance officers or managers, who are responsible for making sure everything is done according to this law so that products can be sold in Europe.
What is the EU Medical Devices Directive (MDD)?
The Medical Devices Directive (MDD) is an older regulatory requirement that was established in 1994. It applied to all devices sold on the European market, which means any device used inside Europe and sold within it is subject to these requirements. MDD applied to a much broader range of medical devices than just those made for export into Europe. This includes all types of devices and software, as well as products that may be used outside the EU.
The MDD was an important piece of legislation for medical device manufacturers because it provides a framework to follow in order to make sure their product complies with European standards. But it lacked certain aspects, which resulted in the creation of MDR. MDD established how companies are allowed to advertise their own products or those of competitors – since MDD rules applied to all products, not just those made for export. One of the key distinctions between MDR vs MDR is that MDDs don’t include additional requirements beyond what items are already covered by EU legislation (such as a CE marking).
MDD vs MDR Comparison
The following table provides a quick MDD MDR comparison:
|Medical Devices Directive
|Medical Device Regulation
New Requirements in EU MDR:
- Certain devices with no intended medical purpose
- Reprocessed single-use medical devices
- Devices for disinfection, sterilization, and cleaning
- Devices incorporating non-viable human tissues
- Ancillary medicinal products
- Active implantable medical devices
Requirements from MDD that are gone:
- Nothing from within the Medical Devices Directive has been removed; instead Medical Device Regulation has added some new requirements.
Important Areas of Change:
- Classes of medical device
- Unique device identification (UDI) system
- Requirements for clinical evaluation, post-market surveillance system, and clinical investigation
- Classification rules
- The person responsible for regulatory compliance
- Stakeholders in the lifecycle of the medical device
What does the MDR bring for medical device manufacturers?
- Easier preparation of the documents and definition of required tests and assessments for the manufacturers
- More detailed requirements for technical documentation
- Established requirements for the Quality Management System
- More strict requirements with the intention to prove the safety of the medical devices for both users and patients
MDR versus MDD: Why did MDD need to be updated?
MDD is outdated. At the time of creating MDD, apps that patients use to monitor their health did not exist, and Software as a Medical Service (SaMD) was not even a concept back then.
Since 1994, the average age in Europe has also seen a significant increase. As a result, this brings greater risks in the malfunction of medical devices. In order to overcome this issue, MDR was established with the purpose of putting stricter regulations on the product life cycle and increasing the overall product hygiene.
Over the years, Europeans have become increasingly conscious of their health. Keeping these factors in mind, there is an increased demand from the consumers for transparency of medical equipment and device technical information.
You may go back to our EU MDR guide.