EU Medical Device Regulations Are Coming – Is Your Company Ready?

The European Commission is drafting the final medical device regulations, and regulatory affairs professionals should already be conducting gap analyses to understand the impact of the regulations on their companies.

The changes will have far-reaching implications across multiple business units, including product development, clinical, regulatory affairs, manufacturing and supply chain operations.

The regulation will add complexity for high-risk devices, particularly when it comes to submissions, said Judith Meritz, strategic advisor at YourEncore, during a recent FDAnews webinar. Also, more products will be classified under the regulation that were not previously classified as medical devices (IDDM, May 27).

The changing role of notified bodies will also have an impact on companies. The notified bodies will need to issue new CE marks, and they’re going to have to ensure those through testing and regular checks on manufacturers, including unannounced inspections, Meritz said (IDDM, Dec. 4, 2015).

Some of the new changes include restrictions on hazardous material such as PVC softeners, and equivalency claims for implantable and high-risk devices will no longer be acceptable. “Companies must conduct clinical investigations and not just rely on equivalency data, which may have been something that you could have done in the past,” said Minnie Baylor-Henry, medical devices practice lead at YourEncore.

Stricter requirements on clinical evidence to support assessments of devices will also impact companies.

For example, there will be a requirement that a summary of safety and performance be submitted to the notified bodies for Class III and implantable devices, and this information needs to be publicly available. The agency also expects greater vigilance when it comes to postmarketing reporting, said Baylor-Henry.

Manufacturers will have new deadlines for reporting serious incidents after causal relationships with devices have been established. In the case of a serious health threat, a report needs to be submitted no later than two days after the devicemaker becomes aware. In addition, periodic safety update reports will need to be filed annually.

One positive result of this is the extended Eudramed database on devices, which will provide comprehensive information on products available in the EU that will translate into better traceability in the supply chain.

Overall manufacturing operations and supply chain operations will be greatly affected by the new requirements on:

• Labeling. Labels must include the notice: “This is a medical device.” Labels must include the unique device identifier, the EU authorized representative and address;
• Reprocessing cycle information required on the label;
• Implant cards for implantable devices. Information must include identification information for the device including UDI and expected lifetime of the device as well as warnings, precautions and instructions for use. The information must be lay friendly and language specific;
• Updated quality manuals and procedures; and
• Recertification for new conformity assessments. Inspections will be more frequent and new technical documentation will be required.

Overall, the new regulations will have a significant impact on the implications around pipelines, and companies should be thinking about the hot spots in their organizations from both a product and function perspective, advised Jon Lange, principal Life Sciences R&D Global Lead at Ernst & Young.

“This really does touch every single part of the business,” he said, “and it’s not just about implants and Class IIIs. It’s really comprehensive. It will affect the products that you market in Europe – every tech file, every label, every one of your core operational processes to some extent or another.”

He advises companies to take a worst and best case scenario approach to determine what steps to take and the inherent costs associated with those steps.

There may be a bright spot at the end of all this though. The competitive landscape is likely to change significantly as a result of the new regulations, and there will undoubtedly be acquisition opportunities or alliances with smaller companies that might not be able to comply with the new regs.

Final publication is expected in late 2016 or early 2017. Devices will need to comply within three years; in vitro diagnostics will have five years to comply. — Tamra Sami