Medical device manufacturers will soon face major changes to the regulatory framework which controls market access to the European Union (EU). In May 2020, the Medical Device Regulation (MDR) will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
The new regulations aim to ensure that products are safe and can be freely traded throughout the EU. The new regulations ensure greater transparency and traceability by enforcing better clinical evidence to support claims of a product’s safety.
The current rules governing medical devices date back to the 1990s, and have not kept up with significant innovations in medical technology.
The implications of the new regulations will be felt in the US and globally—the European medical technology market is estimated to be worth about €100 billion (US $108 billion), around 31% of the global industry. (Source: World Health Organization)
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US medical device manufacturers who want to continue to market their existing products or place new products on the EU market after May 26th 2020 need to work now to implement the new regulatory requirements. Transitioning manufacturers will need to assess core processes including quality assurance and risk management. This blog looks at how the MDR will impact US based companies’ ability to export devices into the EU, and the changes coming with the MDR that device manufacturers should be aware of.
New rules and significant changes
The regulatory changes will see the definition of a medical device significantly broadened to include non-medical and cosmetic devices, which were not previously regulated. Devices such as colored contact lenses, liposuction equipment, epilation lasers, and cosmetic implant devices will now come under the regulations.
Active implantable medical devices and device-specific cleaning products will also be covered by the MDR.
Many medical devices will be reclassified as higher risk, and a new classification for reusable surgical devices has been created.
Under the new rules, manufacturers need to:
- Identify at least one person within their organization who is ultimately responsible for all aspects of MDR compliance
- Provide considerably more clinical evidence to get products to market, or to keep some products on the market
- Recertify all currently approved devices in accordance with the new requirements
- Rationalize their portfolios and conduct global impact assessments so they can implement the changes necessary to remain compliant
- Relabel products and make data publicly available
- Report all incidents, injuries, and deaths in an EU portal that will contain relevant data so patients have access to safety-related information. The deadline for reporting incidents that did not result in death or serious deterioration in health has been changed from 30 days to 15 days.
To give manufacturers an idea of the scope of the changes made to these regulations, the new document is four times longer than its predecessor, and the wording has been changed considerably.
Implementation of unique device identification
The MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that present a safety risk.
UDI will be enforced to help track devices throughout the economic operator supply chain and will be added to all labels.
Potential Impact of Brexit
Brexit has undoubtedly created uncertainty for all businesses trading with the UK, and manufacturers of medical devices have not been sheltered from the effect. It is currently unclear whether the UK will align its regulations for pharmaceuticals and medical devices with the EU. Failure to reach an agreement could result in duplicated regulatory efforts, wasted time, and increased costs for manufacturers.
Cost of compliance will most likely be significant. It is critical that businesses take action now—to gain stakeholder buy-in, prepare their organizations, and start implementing changes. There is a very real need for the industry to be ready for the MDR implementation in May of 2020.
Enterey is a team of high-performing consultants who specialize in the life sciences industry. In the face of increasingly complex regulatory changes and competing business priorities, we recognize that delivering on your promises requires an organizational culture rooted in compliance and transparency.
Our in-depth knowledge of the evolving regulatory landscape in the US and abroad allows us to rapidly diagnose compliance gaps, assess potential quality risks, and develop a foundational quality culture within your organization.
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