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Introduced on May 5, 2017, the EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 aim to improve the safety, performance, and consistent interpretation of medical devices and in vitro diagnostic devices in the EU market.
The MDR became officially applicable on 26 May 2021. Unless transition arrangements allow ongoing market access, medical device manufacturers must comply with mandatory conditions. These requirements are required to introduce their medical devices into the European market from this date forward.
So, what exactly is the EU MDR? This article will delve into a comprehensive overview of the EU MDR, shedding light on its primary objectives, fundamental requirements, and implications for medical device manufacturers.
What Constitutes the EU Medical Device Regulation (MDR) 2017/745?
The Medical Devices Regulation (EU) 2017/745 replaces both the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD). Likewise, the IVDD has been replaced by the IVDR. These new regulations introduce enhancements to the conformity assessment procedures for medical devices with objectives to:
- Enhance the quality, safety, and reliability of medical devices in the European market;
- Increase transparency of device information for consumers and practitioners; and
- Reinforce the vigilance and market surveillance of in-use devices.
To meet these aims, the MDR introduces:
- Revised medical device classification rules;
- Heightened demands for clinical evaluation, technical documentation, post-market monitoring, and vigilance; and
- Enhanced device labelling via a UDI code and data submission to the European Database on Medical Devices.
Understanding the Transition Period and Recent Changes
The EU MDR was initially supposed to complete its 3-year transition period by 26 May 2020. Manufacturers were expected to update their technical documentation and processes during this time. However, the transition to the new regulation encountered setbacks due to unforeseen challenges, such as the pandemic and supply chain disruptions linked to the conflict in Ukraine.
In response to these challenges, the European Union has made important decisions to provide more time for companies to transition to the EU MDR:
- For intricate devices implanted in the body (such as class III custom-made devices), companies now have until 26 May 2026 to make the switch.
- Other complex devices (class III and implantable class IIb) have an extended deadline of 31 December 2027.
- Less complex devices (non-implantable class IIb and lower-risk devices) must transition by 31 December 2028.
- The least risky devices (class I devices with a higher class under the MDR) must also comply by 31 December 2028.
The EU has also changed rules for marketing older medical devices. For instance, devices complying with previous EU MDD regulations can still be sold in the EU post-May 2025 until stock depletion.
Meeting Criteria Under the Medical Device Regulation
Before a device can be sold, it must undergo a conformity assessment and receive a CE mark medical device. For higher-risk devices, this assessment is done by a notified body. Once the evaluation is successful, the notified body gives a certificate of conformity, and the device can be marked with a CE and sold.
Certificates of conformity issued under the old rules are not transferable to the new MDR regulations. Thus, all previously certified devices will require reassessments under the MDR. Here’s what they need to do:
- The device must still follow the old rules and have a certificate from that time. The notified body can’t take back this certificate.
- The design and purpose of the old device shouldn’t change much. The European Commission’s guidance explains what “significant” changes are.
- The old device must be safe for patients, users, and public health.
- By 26 May 2024, manufacturers must have a quality management system (QMS).
- By 26 May 2024, manufacturers must apply to a notified body for the old device’s assessment under the MDR. This application doesn’t need all the details. Still, it should say who the manufacturer is, what the devices are, and their classification.
- By 26 September 2024, the notified body and the manufacturer must agree in writing about some things. This includes the manufacturer telling the body about any issues and the body’s rights to suspend or withdraw certificates.
If these conditions are met, manufacturers can use old certificates of conformity to sell devices in the EU. To prove this, manufacturers need a self-declaration saying they met the conditions. They should also ask the notified body for a “Confirmation Letter” of the application, agreement, and QMS.
EU MDR and the Australian Regulatory Framework: What’s Changin
The adoption of the EU MDR has ushered in a series of modifications for manufacturers of medical devices, encompassing stricter prerequisites for validation, additional criteria governing the quality management systems, in-depth specifications regarding technical documentation, and revisions to the Australia medical device classification criteria.
Given the integration of the EU MDR, many medical devices might need to transition to the new EU MDR criteria to remain approved for Australian distribution.
he Therapeutic Goods Administration (TGA) understands that certain manufacturers are encountering delays in receiving updated certificates from their European-notified bodies. Moreover, the authority acknowledges that the alterations stemming from Europe’s new requirements will consequently impact the products that have gained approval for distribution in Australia.
In an effort to mitigate the regulatory load, financial implications, and disruptions to supply chains, the TGA has opted for an approach that is both risk-sensitive and streamlined. This approach facilitates the transition to EU MDR certification without compromising the safety, quality, or performance of medical devices available in the Australian market. For a detailed understanding, refer to the TGA’s official transition guide.
Conclusion
The EU Medical Device Regulation (MDR) 2017/745 establishes a regulatory framework ensuring a high standard of safety and efficiency for all medical devices available in the European market. While the journey is punctuated with unforeseen challenges, the core objective remains ensuring patient safety. As you navigate the MDR evaluation and compliance process, remember that staying informed and proactive is essential.
Contact Vicki Partridge Today
Reach out to industry experts like Vicki Partridge, a seasoned medical device consultant familiar with both the TGA and global markets, to ensure your company’s smooth transition to the MDR’s rigorous standards.
Whether you plan to import and export therapeutic goods to and from Australia via the European, United States, Asian and New Zealand markets, Vicki is here to help. Contact her at +61 7 55295508 to know more about her services