EMERGO SUMMARY OF KEY POINTS:

• A new medical device industry survey finds many firms still lack a firm understanding of the European Medical Devices Regulation (MDR) and related compliance issues.
• Device manufacturers cite lack of understanding of the MDR as well as shrinking Notified Body capacity as top challenges ahead of the Regulation’s 2020 enforcement deadline.
• Survey conductors provide several recommendations for manufacturers to more fully prepare for MDR compliance.

A new medical device industry survey shows that many medical device manufacturers still lack long-term plans for compliance to the European Medical Devices Directive (MDR) with a 2020 deadline looming.

The survey, conducted by KPMG and the Regulator Affairs Professional Society (RAPS) earlier in 2018, queried 220 medical device companies regarding their MDR compliance efforts. Only 21% of respondents reported having a deep understanding and a strategy for dealing with MDR’s impact, while 41% of companies indicated little to no understanding of the Regulation. Clearly, many manufacturers have a lot of preparation work ahead of them before MDR comes into force.

Obstacles to MDR compliance

Roughly half of all respondents expressed confidence that they will ultimately be able to meet MDR compliance deadlines. In the meantime, however, companies cite two key challenges to more fully preparing for these major European regulatory changes:

Understanding the MDR: Nearly 80% of respondents currently lack sufficient understanding of the MDR, according to survey results. Without sufficient understanding, these firms have yet to finalize strategies to deal with the Regulation’s significant new requirements.

Availability of designated Notified Bodies: As Emergo has previously reported, Notified Bodies’ capacity to audit medical device clients under the MDR presents a major concern for manufacturers active in the European market. Survey respondents also identify availability of designated Notified Bodies as a significant barrier to MDR compliance; the survey report notes that so far, only 19 Notified Bodies have applied for re-designation under the new Regulation, whereas more than 80 Notified Bodies now hold designations under the MDD. Such a scenario increases the likelihood of “orphaned” manufacturers unable to find Notified Body partners necessary for CE Mark certification under the MDR.

Nuts-and-bolts challenges in terms of MDR impact

Respondents also indicated which MDR compliance areas are presenting the most challenges compared to MDD requirements, with 58% of companies stating that clinical data management rules are the most challenging component of the new Regulation. On a related note, an equal percentage of companies have yet to implement a data collection strategy to address MDR clinical requirements.

Firms also identified legacy device management and working with Notified Bodies as significant challenges, as well.

Recommendations for better MDR preparation

Using information from respondents’ replies, survey conductors listed several high-level challenges to MDR compliance, as well as recommendations to address these issue within the MDR’s 2020 compliance timeframe:

• Assign staff and allocate resources to read and become more familiar with the MDR and its requirements;
• Establish and align cross-functional resources and staff to forecast and prepare for business and operational impacts of the new Regulation;
• Consider MDD and/or Active Implantable Medical Devices Directive (AIMDD) recertification under the current grace period in order to mitigate delays in MDR certification due to Notified Bodies’ capacity challenges;
• Establish cross-functional teams to manage relationships with economic operators and meet new supply chain requirements under the MDR
• Develop post-market surveillance (PMS) systems with strong links to risk management functions to help manage quality requirements for new as well as legacy devices in firms’ product portfolios;
• Develop and implement data collection strategies to address MDR’s PMS requirements as well as compliance with the Eudamed medical device database.

Related European Medical Devices Regulation information from Emergo by UL:

• European CE Marking strategy for medical device companies
• On-site European MDR training for medical device manufacturers
• European MDR gap assessment and transition strategy
• Whitepaper: Understanding Europe’s new Medical Devices Regulation
• Webinar: European MDR 2017/745