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 will continue into the spring of 2020. The EU MDR date of application is May 25, 2020; from this date, product approvals should be made following the new EU MDR process.
As the scheduled end of the transition period approaches, here are some of the most frequently asked questions.
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: Are any changes to the EU MDR expected before the end of the transition period?
A: The European Commission is currently reworking the EU MDR, with hundreds of corrections expected. These corrections will aim to clarify issues and provide clear interpretation of the regulation.
Q: If changes happen, could the transition time be extended to allow companies to build technical files and prepare?
A: There is a chance the transition period could be extended due to pressure from manufacturers and trade associations. However, companies should proceed under the assumption it will end in May 2020.
Q: What steps should companies take in 2019 to be compliant at the end of the EU MDR transition period?
A: Companies should be taking several steps now in order to be compliant by the end of the transition period in May 2020. These steps include:
- Establishing strong QMS systems
- Beginning data collection activities, including a bill of materials with accurate manufacturer names, part numbers and part descriptions.
- Preparing to train 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 January 31, 2019.