Medical Device Regulation FAQs
What is the Medical Device Regulation (MDR)?
The Medical Device Regulation (MDR) is a new set of EU regulations governing the production and distribution of medical devices. It replaces and significantly expands on the earlier Medical Device Directive (MDD).
Why has it been introduced?
The MDR has been introduced to reflect technological advances in the industry, such as the use of Software as a Medical Device (SaMD), to provide more transparency and to improve standards of quality and safety.
From when does it apply?
As of May 26th, 2021, the transition period for the MDR has been completed and the regulation is now fully applicable.
How does the MDR define a medical device?
The MDR defines a medical device as any “instrument, apparatus, appliance, software, implant, reagent, material or other article” intended to be used for any of the following medical purposes:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability or injury, where prevention of disability and injury is excluded
- Investigation, replacement or modification of an anatomical, physiological or pathological process
- Providing data via in vitro examination of samples derived from a human body
- Products intended for cleaning, disinfection and sterilization of medical devices
- Devices for the control and support of conception, even if they achieve their intended purpose by pharmacological, immunological or metabolic means.”
What are the key elements of the MDR?
The MDR introduces a life-cycle approach that governs the manufacture, distribution and import/export of medical devices and introduces stricter requirements on clinical evaluation and post-market clinical follow-up. MDR also introduces enhanced traceability throughout the supply chain with the introduction of the Unique Device Identification (UDI) system.
The MDR obliges manufacturers to designate a qualified Responsible Person (RP) and describes the obligations of a broader range of economic operators including manufacturers, distributors, importers and suppliers. The regulation also facilitates the expansion of the EUDAMED database.
What additional devices are now covered by the MDR?
The MDR covers products that were not previously defined as medical devices. These include:
- Contact lenses and other products used in or on the eye
- Products introduced into the body via surgically invasive means to modify the anatomy
- Products and substances used for facial or other subcutaneous fillings
- Equipment used for liposuction, lipolysis, or lipoplasty
- High-intensity radiation equipment used for hair removal and tattoos
- Equipment using electrical or magnetic currents to stimulate the brain
Manufacturers are urged to refer to Annex XVI of the MDR to determine if their products are now governed by the regulation.
What other regulations are coming down the track?
The In-Vitro Diagnostics Regulation (IVDR) is the new EU legislation governing in-vitro diagnostic (IVD) medical devices. The IVDR will complete its five-year transition period and be fully applicable from May 26th, 2022.