Responding to Regulatory Headwinds Buffeting the MedTech Industry
This post is sponsored by IQVIA MedTech.
Today’s medical device and in vitro diagnostics companies are grappling with a range of regulatory pressures, from the legacy Medical Device Directives (MDD) to the new Medical Device Regulations (MDR), to the challenges of tracking changing requirements in markets around the globe. Responding to these pressures will require better use of data, updated process, and harmonization of people and departments to share information across the entire organization.
EU MDR and EU IVDR
One of the most talked about regulatory changes and pressures in the industry’s history is the European Union Medical Device Regulation (EU MDR) set to take full effect in May 2020 and the corresponding European Union In Vitro Diagnostics Regulation (EU IVDR), effective May 2022. Despite widespread discussion of the changes and the transition period from MDD to MDR that has been ongoing since 2017, many MedTech firms are still underprepared, says Caroline Freeman, MedTech specialist and senior consultant in IQVIA’s quality and regulatory compliance center of excellence.
The industry-wide headwind from MDR and IVDR is of typhoon proportions. Ranging from product reclassifications, to new CE-certifications, to lack of required data, to new reporting requirements – not to mention a shortage of notified bodies to provide the necessary certificates, before a quickly approaching deadline. Time will tell the full supply chain impact these regulation changes will have, including product availability or not, and the patient impact in certain markets where products are pulled from the market.
Amplified by the fact that most companies have leveraged their CE-mark to gain certification in multiple other markets outside of the EU, those too will be impacted where there is a go-forward need to get a new CE-certification under the MDR/IVDR.
Weathering the Storm
“The impact of these regulation changes is likely to be a decade-long impact,” says Freeman. MedTech companies are now under pressure and are trying to quickly come into compliance by upgrading or replacing their Quality Management Systems with those that include MDR/IVDR regulatory compliance built-in, and/or through insourcing additional resources -- hiring consultants and people that understand the MDR well enough to assist.
Considering the additional data and reporting requirements, and the vigilance reporting window being reduced from 30-days to 15-days, companies will quickly realize that people-alone is not a sustainable answer. Companies wishing to get ahead of the curve will apply technology and automation to improve efficiencies. Three quick examples include:
- Integrated quality compliance, Quality Management Systems, with built-in MDR for regulatory reporting compliance
- Regulatory Intelligence Data, updated every 20 minutes for global regulatory changes across 100 countries, integrated with Regulatory Management and Document Management for centralized control, and orchestration with Quality Management for reporting, management, and auditability across the enterprise and extended enterprise
- Machine Learning and Artificial Intelligence applied to improve early identification and automate case entry, based on social signals and other data, to facilitate and expedite adverse event capture and management.
Ultimately, we’ll see more MedTech companies take a page out of the pharmaceutical industry’s playbook, and they will turn to outsourcing much of the vigilance and safety and real world evidence processes to managed services and data experts so they can focus their inhouse resources on more value-add core processes.
Change Can Mean Opportunity
With the proper systems, updated procedures, and partners in place, MedTech firms can turn this time of new regulations and change into a business advantage.
Those that can adapt use regulatory challenges as a driver to improve and integrate orchestrated processes and staff across the entire enterprise will be more compliant, more innovative, and more efficient over the product lifecycle, Freeman reinforced.
IQVIA MedTech solutions and services help medical device and diagnostics companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes safely forward. Learn more at www.iqviamedtech.com.