“This is the most significant change to the EU regulations in more than 26 years.”
Companies in the business of marketing medical devices to the European Union are facing a new world of regulations aimed at tightening controls to ensure safety and efficacy and improve industry competitiveness beginning May 2020.
“This is the most significant change to the EU regulations in more than 26 years,” says Bill Kurani, the head and director of regulatory affairs and quality assurance at a Silicon Valley-based global genomics company. Kurani, an instructor in the UCSC Extension Regulatory Affairs and Medical Device certificate programs, has secured regulatory and marketing approvals for medical devices, in vitro diagnostic devices and drugs from the FDA, the EU, and other global regulatory agencies over the past 20 years.
Scrambling to be Ready
The new regulations adopted in 2017, are scheduled to go into effect May 26, 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.
“It’s an excellent change,” Kurani says. “Products will be safer, have more benefits, and patients will be better informed thanks to new levels of required transparency.”
But, he adds, the May 2020 deadline is fast-approaching and companies are scrambling to prepare for the dramatic changes.
The World Trade Organization, which estimates U.S. products contribute $20 billion to the $125 billion EU medical device market, has called for a three-year delay in implementation, claiming the EU hasn’t sufficiently ramped up its new oversight structure.
“For large companies with many products, preparation could cost millions of dollars,” Kurani says.
Companies that don’t adequately prepare or receive an extension could lose the ability to market existing products in the EU and face production delays on new products.
“If medical devices companies have existing products, they need to take them to a Notified Body and ensure they can still be on the market or they would have to retire them,” Kurani says. “For new products, companies need to understand what it takes to go through the new regulations and get approvals and registrations before marketing them.”
New Overview Course for Seasoned Professionals
Kurani has developed a new comprehensive course—European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance—that dives deep into the most critical areas of change. It is a 11-week course aimed at seasoned professionals in the regulatory affairs and quality assurance industries.
For professionals in the field—including regulatory affairs, quality assurance, research and development, marketing, customer support and manufacturing—as well as new graduates seeking employment in the industry, Kurani recommends they learn with real life examples.
Course topics include:
- Conducting a gap assessment of the existing and new medical devices for an organization;
- Understanding medical device classification and conformity assessment;
- Analyzing costs associated with the new clinical evidence requirement for new and existing medical devices;
- Creating summary technical documentation; and
- Deploying post market surveillance and reporting of serious incidents and field corrective actions.
The course will include tools and medical device templates to support strategic cost savings during deployment.
“If you want to start implementing new medical device regulations for your organization, you should start today,” Kurani says.