In the past several years, many changes have been made to the regulations and rules governing the medical device industry—and there are still more to come.
While regulatory changes are not entirely worrisome to larger manufacturing companies, smaller companies who have fewer funds and resources often find it difficult to adapt to regulatory changes. As new and revised regulatory standards loom before us, it is in these smaller companies’ best interests to prepare for the coming changes.
According to market research, regulatory transition pace has increased in the last few years, which has made it easier to pass concurrent changes. In 2018, for example, the FDA issued 65 new guidances. With so many new things to contemplate and remember, companies are struggling to meet requirements. Additionally, due to the medical device industry’s fierce regulatory environment, there are less innovated products and high-risk technologies (those for which a comparable product is not available) being developed and marketed, which poses various problems for the development and health of our nation.
Those who don’t adequately plan for regulatory changes could face fines and penalties in the future, so it is vital to be aware of this field’s shifting landscape. Following are a few regulatory standards for which to prepare.
ISO 13485
In 2016, ISO 13485 was revised to include emphases on risk-management and risk-based decision making. This revision also introduced the idea of global regulation harmonization. This standard will be revised in the future to adapt to a changing medical climate—and it won’t take 13 years, as it did previously. Manufacturers should note that the FDA plans to replace 21 CFR Part 820 with ISO 13485 in the near future.
ISO 14971
The latest revision to ISO 14971, which will be published later this year, will define the international standards for the risk management of medical devices with clarifications to the definitions of “benefits” and “risks” stated in the current version.
Before this standard is published, manufacturers should determine whether or not they are compliant and identify their internal and external risk management proprietors.
EU MDR 2017/745
On May 26, 2020 the European Union’s MDR 2017/745 will go into effect. Any medical device manufacturer marketing products in the European Union must comply with this new regulation.
MDR 2017/745 supersedes MDD and includes software-based medical devices. Its new regulations provide manufacturers more responsibility throughout their products’ lifecycles, which means that manufacturers must be aware of the changes encompassed within the document. The MDR delineates new requirements pertaining to the following:
Post-market Surveillance Systems
Periodic Safety Update Reporting
Incidents and Field Safety Corrective Actions Reporting
Resource and Supply Chain Management
Unique Device Identifiers
Labelling
Regulatory Compliance
Document Management
Safety and Performance
Implantable Devices
Clinical Evidence
Economic Operators
It is imperative to begin preparation for the coming changes in May of next year, as the cost of compliance will increase. In addition, approved Notified Bodies capable of handling the bandwidth of medical devices that require audits and CE marks must be contacted prior to the transition date. There are currently only four Notified Bodies approved under the MDR, which means that manufacturers will struggle to find a Notified Body to certify their devices.
Because global harmonization is a trend that will continue into the future, manufacturers should anticipate further revisions and introductions to medical device regulations. Those who anticipate these changes and adapt in a timely fashion will grow as strong competitors in this field. Rhein Tech Laboratories offers electromagnetic compliance testing in accordance with the standards for the medical field. Our team stays up-to-date on all regulation updates—and we like to keep our clients in the loop too. Contact us today for a quote and subscribe to our monthly e-newsletter to make sure you’re caught up on international standards updates by emailing your request to sales@rheintech.com.
Sources:
https://incompliancemag.com/article/a-tsunami-of-regulatory-changes-is-coming/, https://www.odtmag.com/issues/2018-02-01/view_columns/the-impact-of-us-regulation-on-medical-device-innovation/