For almost 30 years, the European Union Medical Device Directive (EU MDD) was the standard by which European nations regulated the production and distribution of medical devices. In 2021, however, a new set of rules called the EU Medical Device Regulation (EU MDR) superseded the MDD with the purpose of improving Europe’s medical devices and the safety of the people who use them.
As the United States International Trade Commission points out, the EU is home to the world’s second-largest medical device market, and the United States is its leading supplier, so the MDR is likely to have significant impacts on American firms. To be prepared, manufacturers and distributors should be aware of the particulars of European medical device regulation and how it may affect costs and time to market.
What’s currently happening with the EU MDR?
Currently, all manufacturers selling medical devices in the EU must comply with the rules set forth by the MDR. In the words of Stella Kyriakides, the European Commissioner for Health and Food Safety, these rules represent “an important step forward for the protection of patients across Europe,” as they improve safety, elevate quality, increase transparency, and reduce administrative burden.
Already, the MDR has helped to streamline the adoption and enforcement of the new rules governing medical devices in the EU. According to EU law, directives are subject to transposition, whereby individual member states must incorporate them into their respective national laws by a specified deadline. Transposition doesn’t apply to regulations, however, so the MDR is directly applicable throughout the Union without additional process.
The Key Differences between the MDR and the MDD
Compared to the MDD, the MDR is more specific in its scope. While the former broadly covered medical devices and accessories, the language of the latter addresses the following areas in particular:
- Active implantable medical devices
- Devices incorporating ancillary medicinal products, including those derived from human blood or human plasma
- Devices incorporating nonviable tissues, cells of human origin (or derivatives)
- Devices manufactured using tissues or cells of animal origin (or derivatives) that are nonviable or rendered nonviable
- Products specifically intended to clean, disinfect, or sterilize devices
- Aesthetic products without an intended medical purpose listed in Annex XVI of the MDR
The MDR is also more comprehensive. In its 174 pages, it spans 123 articles and 17 annexes, as opposed to the 23 articles and 12 annexes of the defunct MDD. Not only that, but it encompasses the same rules as the MDD but adds four new ones to account for developments in medical device technology:
- Rule 19 relates to devices consisting of nanomaterial.
- Rule 20, to invasive devices being classified as IIa.
- Rule 21 provides classification guidelines for devices containing substances, or combinations of substances, introduced to the body topically or through an orifice.
- Rule 22 addresses active therapeutic devices with integrated or incorporated diagnostic functions.
The Main New Features of the EU MDR
The MDR introduces the following new features that further distinguish it from the MDD:
- Unique device identifiers (UDIs), which allow for specific identification of medical devices on the market
- Increased emphasis on post-market surveillance, requiring device manufacturers not only to monitor the performance of the products they put on the market but also to take corrective measures when necessary
- Increased responsibility and improved performance of notified bodies, EU-designated organizations that assess and certify medical devices
- Clearer requirements concerning the clinical data required for medical devices, and the assessment thereof
- Stricter premarket control for high-risk devices, involving a pool of experts at the EU level
- Requirements concerning the reprocessing of single-use devices
- Establishment of EUDAMED, a comprehensive EU database on medical devices, a large part of which will be available to the public
What’s upcoming with the EU MDR?
Full transition to the EU MDR will be a yearslong process, with the EU having set deadlines by which manufacturers must certify their devices. Previously, medical device manufacturers had until May 26, 2024 to recertify their products and get them to market under the EU MDR. However, as more than 21,000 medical device certifications were set to expire by that date, and notified bodies estimated they could issue only around one-third of the necessary MDR certificates in time, the original deadline would have led to a drastic shortage of medical devices in the European market.
Extended Transition Deadlines
To address the issue, the EU introduced an amendment that automatically extends the certificates of certain legacy devices and gives manufacturers more time to comply with the new rules. Specifically, devices that held valid certificates on May 26, 2021, may remain certified and available on the market until the following dates:
- May 26, 2026: class III custom-made implantable devices
- December 31, 2027: class III and class IIb devices
- December 31, 2028: class IIa and IIb devices; class I sterile devices; class I devices with measuring functions; and devices that previously qualified as class I under the MDD but now require the intervention of a notified body under the MDR
Conditions for Eligibility of Deadline Extensions
The amendment doesn’t apply to all medical device manufacturers and legacy devices. To qualify for the extended dates, manufacturers must:
- Apply for a new MDR certificate with an MDR notified body before the expiration of their MDD certificate.
- Apply for said certificate by the original deadline of May 26, 2024.
- Have a contract in place with an MDR notified body before September 26, 2024.
The Impact on American Manufacturers
As mentioned, U.S. manufacturers are the leading supplier of medical devices on the European market. As such, they not only play the main role in complying with the new rules but also represent the largest segment of entities impacted by the EU MDR. Below are some of the major challenges that U.S. manufacturers can expect to face as Europe transitions to its new system of medical device governance:
- Additional compliance costs: EU MDR compliance procedures—particularly the stronger emphasis on clinical trials and the implementation of unique device identifiers—cost money to fulfill. The total cost of compliance can run upwards of $1 million, a sum that is prohibitive to many firms.
- Additional time to receive market approval: Given the stricter premarket control, particularly for products classified as high-risk, notified bodies are likely to need more time to assess devices for certification, which translates into longer waiting periods for manufacturers to receive approval.
- Delayed approval times: We can expect delays on multiple ends as entities strive to catch up with the regulations introduced by the EU MDR. Manufacturers, for example, may see slowdowns because of the new clinical trial, labeling, and registration requirements, while notified bodies face the challenge of keeping pace with the sheer volume of certifications they’ll need to work through.
It’s evident that, for U.S. manufacturers, the impacts will be broad, as even MDD-certified devices must become recertified under MDR, and the MDR’s reclassifications of certain medical devices may compel adjustments to once-familiar premarket procedures. If they wish to remain in the sizable EU market, they must be prepared to reshape their approaches around the new requirements.
The Path to Compliance: Smart Staffing with Medix
Successful transition to the EU MDR relies on having staff that understands the intricacies and nuances of the new rules. In particular, it’s an issue of quality over quantity. Organizations should lean toward hiring talent with heightened attention to detail because of the remediation activities that may be necessary to ensure compliance. Because the EU MDR has significantly more articles and annexes than the MDD, your staff will likely need to begin reshaping organizational procedures by performing a gap analysis, weighing current processes against MDR requirements. Doing so involves the development of a methodical timeline with appropriate project management resources.
It’s also vital to hire professionals with a deep level of compliance experience in either medical device or life sciences in general, as they can apply their experience interpreting rules and regulations and implementing procedures and processes to adhere to them. It may require a creative staffing approach to find this specialty talent, perhaps utilizing a blend of direct, permanent hires, complemented by contractors or temporary workers. The right staffing agency can alleviate the pressure on your internal HR team to find these candidates.
Speaking of staffing agencies, it may be difficult to find the ideal partner, but it is also crucial. An experienced, specialty firm like Medix can increase your organization’s capacity to adapt to not only the EU MDR, but to a continuously shifting medical device landscape. We have two-plus decades of staffing experience in medical device engineering, clinical research, and other areas that help advance the process that brings devices to the market. Plus, with our nationwide pool of talent and strict screening processes in these areas, we can match your organization with fitting candidates quickly, putting you on the path to compliance—and market.