Medical device standards and regulations have changed significantly in recent years, but one of the biggest changes to be released is the pending transition of the Medical Device Directive to the Medical Device Regulation. This update will have widespread industry impact, some of which is not yet fully understood. Some changes are minor and designed to align to other existing procedures, while other updates represent significant changes.
Why is this change coming?
The 2007 regulations are dated, going on 11 years old. During that time, several events have revealed weaknesses within the existing standards. These are addressed through the new regulation’s additional focus on post-market surveillance, patient communication, and more demanding clinical testing. This increased patient focus was summarized in an April 2017 press release:
“The new Regulations pave the way to a more patient-friendly environment, where transparency and patients’ information and choice are a priority . . .” – European Commission Press Release (5 April 2017)
When is the change happening?
The updated regulation was released April 2017 and becomes effective in stages. The Medical Device Regulation (MDR) will fully apply May 26, 2020 and the In Vitro Diagnostic Regulation (IVDR) will apply on May 26, 2022. By the final deadline of May 26, 2024, all devices on the market must be certified to the updated regulation.
What is changing?
While several sections have seen little to no updates, there have been some extensive changes, including several with significant revisions that could require major updates for many companies:
- Unique Device Identifier (UDI): Every medical device must now be uniquely identified to help increase traceability. This standard will not be entirely new for US manufacturers but is new to this regulation.
- Post-Market Surveillance: A surveillance plan is required for every medical device and periodic monitoring is expected as part of the new regulation.
- Notified Bodies: There is a significant role change with notified bodies, as they will now be considered the primary enforcers of this regulation and will therefore be more heavily supervised. There will be mandatory consultation requirements and unannounced audits from these bodies to enforce the new requirements.
- First Time Additions: There are several first-time inclusions under the updated regulations that interpret the idea of an implantable medical device more broadly than before. This includes but is not limited to: contacts (both vision correcting and cosmetic), any product introduced totally or partially into the body (excluding tattoos and piercings), lasers used for tattoo or hair removal, and electrical equipment designed to modify brain activity.
Who is impacted?
The 2017 MDR update will have wide-spread impact on the industry. First-time inclusions will impact a number of companies not affected by the 2007 version. Companies with significant import/export and distribution activities will also see significant requirement changes . Even companies compliant to the 2007 standard could face a massive effort to register new UDI’s for every impacted product.
What are the next steps?
One of the first steps to identifying the impact on your business is to understand the response of your notified body. Because changes in the 2017 standard include alterations to the treatment of notified bodies, their responses and expectations will vary. Understanding your notified body’s response could help guide your immediate reaction to the regulation. Due to the many changes, a next step gap assessment will help to identify the exact impact areas for your business.
To help determine the impact of the 2017 regulation on your company and products, a Medpoint consultant can review your procedures against the new requirements and help develop an action plan to prepare your team for the changes ahead. To learn more, contact us at firstname.lastname@example.org or 800.200.9292.