New EU Medical Devices Regulation/In Vitro Diagnostics Regulation
Challenges and transitions
19 June 2020
The medical sector plays a crucial role not only to the health of European Union (EU) citizens but to the European economy as well. The medical devices market in the EU contributes to one-third of the global market, at around €110 billion (Source: European Commission website).
On 25 May 2017, two new regulations on medical devices and in vitro diagnostic medical devices entered into force in the EU: Medical Devices Regulation (EU) 2017/745 (“MDR”) and In Vitro Diagnostics Regulation (EU) 2017/746 (“IVDR”). Due to the COVID-19 pandemic and increased demand for medical devices, the European Parliament agreed to the EU Commission’s proposal to postpone the application of the MDR by one year. The MDR will therefore come into effect on 26 May 2021 instead of 26 May 2020. The IVDR will remain unaffected by the new proposal and will come into effect on 26 May 2022, as planned. It is essential that the majority of medical producers around the world are compliant with the EU MDR/IVDR.
Hundreds of thousands of products will need to be re-certified in order to continue being sold in the European market. All previous certificates under Directives 90/385/EEC, 93/42/EEC, and 98/79/EC will become void on 27 May 2024. Although there is a one-year “grace period”, medical device manufacturers should not delay their compliance efforts with the new MDR/IVDR and should begin the certification process as soon as possible.
The first step in becoming compliant with the MDR/IVDR is to determine whether your product falls under the scope of the MDR/IVDR. If your product has an intended medical use, compliance is mandatory. Secondly, you must determine the classification of your device. General safety and performance requirements apply to all medical device classes, as well as the design phase in the manufacturing process. Additional steps include the development of quality and risk management systems, as well as conducting a benefit-risk analysis and clinical evaluations. Manufacturers are also required to supply label information, including instructions of use.
The MDR/IVDR obligates the manufacturer or authorized representative in the EU to generate the technical documentation and sign the declaration of conformity. All technical documentation must be kept for 10 to 15 years depending on the device type.
The new MDR/IVDR will create improved transparency through a comprehensive European Database on Medical Devices (EUDAMED) and a device traceability system based on the Unique Device Identification (UDI) of each device. Each device must be registered using a Basic Unique Device Identification-Device Identifier (UDI-DI). Accordingly, Manufacturers must draw a post-market surveillance technical file to show how the performance data about their device is collected. Indeed, the new regulations offer better coordination mechanisms and post-market surveillance.
If you are a manufacturer and would like to improve your understanding of your regulatory responsibilities, Intertek can help. Our scientific and regulatory experts are available to assist companies in meeting MDR/IVDR compliance requirements.
For further information on how Intertek can help you place your medical devices onto the EU market, please don't hesitate to contact us.