The European MDR: Impetus, Impacts, And Current Status

Adopted in the early 1990s, the MDD are composed of three directives: the Supplementary Directive for In Vitro Devices, the Supplementary Directive for Implantable Devices, and the Primary Medical Device Directive. Although the MDD served their purpose well and played a significant role in the success of the European medical device market over the past three decades, the Directives’ weaknesses have rendered them somewhat ineffective in today’s medtech world:

• Outdated regulations: The MDD did not keep up with technological developments (and the regulatory challenges they incur) in the medical device space, particularly as it relates to hybrid devices and medical software.
• Lack of consistency: Because the MDD were directives (as opposed to regulations), they did not supersede the laws of individual countries; as a result, there was some variation in how they were implemented across the various member states.
• Focus on approval, not postmarket performance: Following approval under the MDD, device performance was not tracked in a particularly useful or accessible way, and continued clinical assessment was not mandatory.
• Narrowly focused accountability: Liability for device issues and failures fell on the original manufacturer, without accounting for other companies in the supply/distribution chain; this led to a lack of accountability for other parties involved in the supply of medical devices.
• Insufficient scrutiny on notified bodies: Notified bodies had (NBs) focused on one-time/premarket assessments and approval, behaving as industry partners for manufacturers, focusing on approval rather than device safety and quality.

• Monitor the ongoing release of guidance documents and legislative changes relevant to the MDR.
• Conduct portfolio assessment to determine how your products will be classified under the MDR; consider whether divestment or prioritization of certain products will be necessary; ensure legacy products are recertified by the application deadline.
• Update processes and procedures to meet MDR requirements — these activities include establishing or updating your compliance plan and quality-management systems, particularly for postmarket surveillance and postmarket clinical follow-ups.
• Review all of your product documentation to eliminate any gaps in clinical data and technical documentation record-keeping.
• Secure a suitable Notified Body; share your compliance plan.
• Following product launch, ensure availability and accuracy of all required postmarket systems and documentations.