What Device Makers Need to Know About Changes in EU Regulations – Part II: Medical Devices

In the 1990s, metal-on-metal hip implants were introduced to Europe as a safer, sturdier alternative to metal-on-plastic hip implants. Physicians implanted tens of thousands of these devices.

But physicians later found these implants put patients at risk for muscle damage and heavy metal poisoning. In fact, the UK Medicines and Healthcare products Regulatory Agency recently recommended that 56,000 recipients undergo blood tests to assess their need for revision surgery.

To prevent such hazardous devices from reaching the market, the European Union recently introduced sweeping changes to medical device regulations that aim to centralize regulatory oversight of device development.

In the first part of this series, we discussed new regulations for IVD manufacturing that go into effect in 2022. In this post, we discuss the medical devices regulations (MDR) that go into effect sooner, in 2020.

To comply with the new MDR, we recommend manufacturers begin changing their protocols now. A medical device CRO can perform gap analysis of a manufacturer’s documentation, protocols, and procedures to generate a list of items the manufacturer needs to update. Novella Clinical has the expertise to identify gaps in clinical evidence under the new rules not only for devices that are currently in development, but also for recently approved and planned devices.

Significant Changes to Device Regulations

The MDR includes new EU rules that aim to enhance the safety of medical devices. The new rules account for recent technological innovations that make devices safer, as well as boost innovation by introducing several new changes that centralize and streamline the regulatory process. These changes include:

  • Control high-risk devices by independent experts panels
  • Centralize protocol assessment and device registration
  • Expand the European Database on Medical Devices (EUDAMED) and the use of Unique Device Identifiers (UDIs)

1) Expert Panels for High Risk Devices

The new MDR imposes additional responsibilities on Notified Bodies, including an extra pre-certification checkpoint for high-risk devices. Notified Bodies must consider the opinions of independent expert panels at the EU level and either address the panels’ concerns about the device’s safety or provide justification for not following their advice. Experts for the panel will be recruited by the European Commission. The panels are expected to minimize the prevalence of inconsistent feedback that presently occurs due to reliance on expertise of national Notified Bodies.

2) Central Assessment and Registration

The new MDR introduces further measures aimed at strengthening the EU’s role in monitoring medical device development. Previously, device development was largely decentralized, subject to the regulations of each Member State. Under the new regulations, clinical trials that take place across multiple Member States will be subject to a single, mandatory, coordinated assessment. This eases the flow of information between Member States and allows for more informed regulatory decision-making by the European Commission.

This new protocol, however, will introduce new demands on manufacturers relating to clinical evaluation and investigations, including a mandatory post-market clinical follow-up and periodic completion safety update reports. Novella Clinical can help manufacturers navigate these new responsibilities.

The MDR also centralizes device registration. Previously, manufacturers were required to register their new devices in each Member State in which they planned to release it. Now, manufacturers only need to register their devices with the European Commission once in EUDAMED.

3) EUDAMED and UDIs

By 2020, the European Commission will expand EUDAMED. The database will track the lifecycle of all commercially available devices by capturing the activities of all involved parties, including manufacturers, suppliers, Notified Bodies, and other stakeholders. The database will also include product information and safety and efficacy data.

Most of the data contained within EUDAMED will be made publicly available by the European Commission. By doing so, they expect to promote innovation and accelerate progress in medical device development. For high-risk devices, manufacturers must supply a summary of clinical evaluation of the device, which will be publicly available. Novella Clinical can help manufacturers generate these reports so a lay audience could comprehend them.

To enhance its traceability and transparency, the new MDR also requires that each device in the database be tagged with a UDI. These UDIs must be placed on a device’s package or label and must be tracked by every actor in the device’s supply chain, including manufacturers, who must submit UDIs to EUDAMED.

Do you have a question about the new EU regulatory standards? Ask us.

Click to learn more about Novella Clinical’s medical device experience.

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