At the start of a new year, Emergo takes a look back at what we believe were some of the most important developments of 2016 for the medical device regulatory field worldwide.
News from Europe and the US feature prominently, but so do international issues such as the publication of ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP) for quality system audits.
Publication of the ISO 13485:2016 quality system standard
Updates to the ISO 13485 quality system standard for medical devices finally arrived in early 2016, and the impact of the standard’s latest iteration for manufacturers worldwide cannot be overstated. Although manufacturers have three years to add ISO 13485:2016 changes to their own quality management systems, that timeframe will be needed for effective implementation and compliance planning.
European draft Medical Device and IVD Regulations unveiled
After years of anticipation, European regulators released draft Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) in June 2016. Obviously, publication of the new Regulations has prompted questions from industry regarding complex implementation time tables, new CE Mark certification requirements and major changes to relationships with Notified Bodies and Authorized Representatives.
Ongoing Notified Body shakeup in Europe
European medical device industry observers have predicted a tighter Notified Body market for CE Mark registrants as stringent new NB requirements take effect. Stronger Competent Authority oversight of NBs may lead to fewer NBs willing or able to operate in Europe, potentially “orphaning” manufacturers whose NB partners no longer support them. In late 2016, the French Competent Authority acknowledged these challenges, issuing “denotification” recommendations for device companies whose NBs cease operating in Europe. Emergo consultants anticipate other Competent Authorities adopting similar or identical recommendations.
21st Century Cures Act and the US FDA
In the final weeks of 2016, the US government enacted a new law, the 21st Century Cures Act, which includes several changes to how the Food and Drug Administration reviews and oversees medical devices in the country. The new law’s impact on the agency’s device classification and review processes as well as clinical trial requirements will dominate the US medical device regulatory environment in 2017.
Reimbursement trends versus device innovation in the US
The influence of General Purchasing Organizations and large health insurers in US medical device purchasing and reimbursement was one of the stronger trends identified in Emergo’s 2016 industry survey. One potential downside of such influence on procurement decisions, however, may be that larger organizations’ purchasing clout may be stifling smaller, cutting-edge device manufacturers according to our analysis.
The Medical Device Single Audit Program (MDSAP): Ready for prime time?
MDSAP is scheduled to shift from pilot to fully operational mode in 2017, allowing market registrants in the US, Canada, Brazil, Australia and Japan to leverage a single quality system audit report in order to satisfy regulatory requirements in any of these participating countries. But are participating regulators actually willing to launch MSDAP? According to Emergo consultants as well as MDSAP administrators themselves, greater buy-in from manufacturers has proven a persistent issue in 2016.
US FDA’s final word on post-market surveillance
US regulators took steps to beef up post-market surveillance requirements in 2016, issuing final guidance for various types of higher-risk Class II and III devices. The FDA’s latest approach to post-market surveillance followed a 2015 study that found the agency’s existing resources and capabilities in this area inadequate to address a market with the size and complexity of the US.
Cybersecurity and risk management: The FDA’s take
In early 2016, the FDA identified six key components for effective cybersecurity risk management that manufacturers of relevant devices and software products should incorporate into their post-market surveillance systems. Given that cybersecurity risks present a relatively new and fast-moving challenge for the FDA and other medical device regulators, additions and revisions to these recommendations will likely appear in 2017.
Updated European clinical evaluation requirements
While the new MDR and IVDR commanded most attention among European industry observers in 2016, the European Commission also substantially revised guidelines for clinical evaluation reports. Under MEDDEV 2.7/1, Rev. 4, medical device clinical evaluation reports (CERs) must more extensively address risk management issues and post market surveillance, as well as equivalence data requirements.
Better premarket review timeframes in Japan
A 2016 Emergo analysis of Japanese Pharmaceutical and Medical Devices Agency (PMDA) data shows signs that the regulator of one of the world’s largest device markets has begun improving premarket review timeframes in recent years, likely due to coordinated efforts between the PMDA and industry. These improvements may particularly be attributable to the Collaboration Plan to Accelerate Review of Medical Devices, launched in 2014.
