Update (2020-04-23): due to the COVID-19 pandemic, the EU MDR date of application has been postponed by 1 year, from 26 May 2020 to 26 May 2021. The possibility for EU-wide derogations for certain critically-needed devices has also been codified. For more information, see Regulation (EU) 2020/561 (link).
The European Union (EU) Medical Device Regulation (MDR) EU 2017/745 entered into force on May 25, 2017, with the aim of improving clinical safety and supporting fair market access for manufacturers.
The transition period for the regulation continued into the spring of 2021. The EU MDR date of application was May 25, 2021; from this date, product approvals must be made following the new EU MDR process.
Here are some of the most frequently asked questions about EU MDR.
Q: How is the new EU MDR different from the Medical Device Directive (MDD) and the EU’s Directive on Active Implantable Medical Devices (AIMD)?
A: The new EU MDR replaces the existing MDD and AIMD regulations. Product approvals under the EU MDD and AIMD can potentially remain in force until May 25, 2024, for legacy products.
Q: What products are in scope of the EU MDR that weren’t covered by MDD and AIMD?
A: The new EU MDR rules will also cover products for aesthetic use which weren’t previously in scope, including:
- Colored contact lenses without vision correction.
- Facial dermal fillers.
- Equipment for liposuction.
- Lasers for skin treatments, tattoo removal and/or hair removal.
Q: What are the new requirements for medical devices under the EU MDR?
A: Based on a device’s risk level, manufacturers are required to follow a specific process before it can enter the market. These steps include:
- Developing an internal Quality Management System (QMS).
- Surveying suppliers for data to build a technical file based on the EU MDR substance list.
- Compiling a Declaration of Conformity for the device.
- Gaining approval from the applicable notified body.
- Entering device data into UDI and EUDAMED databases.
Q: How many products are in scope of the EU MDR?
Out of 500,000 existing medical devices, 314,000 need to be recertified under the EU MDR.
Q: What steps should companies take to be compliant with EU MDR?
A: Companies in scope of EU MDR should take a number of steps to comply with its requirements. These steps include:
- Establishing strong QMS systems
- Beginning or continuing data collection activities, including a bill of materials with accurate manufacturer names, part numbers and part descriptions.
- Training suppliers, if necessary, about the EU MDR and the new substance list.
- Allocating the proper time to map supplier responses and roll up data.
Assent’s EU MDR Module helps companies collect and manage supply chain data to maintain market access, and reduce risk. To learn more, email firstname.lastname@example.org.
Learn more about the EU MDR by downloading our eBook, Understanding the EU Medical Device Regulation.
This information is accurate as of March 2022.