The EU MDR is a new set of regulations that came into effect on 26th May 2021, following a 4-year transition period after being adopted in May 2017. It aims to improve the safety and performance of the device throughout the lifecycle by tightening up the requirements and adding more emphasis on the market vigilance which was missing when the previous MDD (Medical Devices Directive) law was passed in 1992.
Similarly on 26th May 2022, the in vitro Diagnostic Medical Devices Regulation (EU IVDR) will come into effect for all the EU member states. However, the EU MDR & EU IVDR will not apply in Great Britain. The UK’s regulation for medical devices will continue to act based on MDR 2002 for now, which was implemented in the UK by the Medical Devices Regulation 2002.
The need to setup a new MDR
When the MDD came into force in 1992, there was no concept of software as a medical device (SaMD) at that time. Other technology advancements throughout the supply chain have also enhanced general traceability and transparency as well.
Also, an aging population in Europe needed the devices to not only pass clearance to be sold in the market but to also provide enhanced usability and transparent technical information for increased patient safety.
Although the renewal of MDD certification is still allowed for three more years until 26th May 2024, devices would ultimately need to be compliant with the MDR. This increased time is to allow for a smooth transition without market disruption.
Understanding the grace period
A second set of corrections was published by the Council of the European Union for the MDR which gives manufacturers of certain Class I low risk devices under the MDD, another three years to be compliant until the 25th of May 2024, provided that these devices do not have any significant changes.
This additional time can benefit the manufacturers of Class I devices by allowing them time to make the necessary revisions and complete an MDD CE certification. Which means that all devices approved and lawfully placed on the market can continue to be sold until 26th May 2024.
The way forward
Even if your company is compliant with MDD, MDR brings in many new regulations and replaces many others, so it is important to make sure the devices are compliant way before the deadline.
The new regulation also states the obligation of manufacturers and distributors to have a stricter clinical evaluation & conformity assessment procedure in place while focusing on the risk management and quality management systems at the same time. It is advised to start the transition from MDD to the MDR earlier as the last-minute approvals could affect business continuity for devices that have a large inflow into the market.
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Reach out to CosmoTrace for support getting your technical documents ready for MDD renewal or the MDD to MDR transition. We have expert medical writers to support your organization with the implementation of regulation, project management, risk management, quality management, consulting, and reporting to the authorities.