EU Medical Device Regulation (MDR) Compliance

As of April 2017, the EU adopted 2017/745 Medical Device Regulation (MDR), thus restructuring the current European regulatory landscape and further impacting manufacturers who were previously exempt from medical device regulation. Part of the changes introduced in the regulation included broadening the definition of a medical device to include non-medical and cosmetic devices not previously regulated. The compliance date for MDR was recently extended to May 26, 2021. The final cutoff for the expiration of MDD and AIMDD is May 2024.

A new and more defined approach that involves the overall life cycle of a medical device has been introduced with the MDR. Manufacturers are now required to declare their own compliance and maintain supporting documentation.
Device certification under MDR mandates becoming more closely aligned with U.S. Food & Drug Administration regulatory requirements, thus requiring more information from the manufacturer. Technical file submissions will include more detailed information on clinical data, marketing claims, and postmarketing data. For example, Article 10 in the EU MDR calls out the key quality management requirement for manufacturers; Annex I outlines over 100 general safety and performance requirements (GSPR). The emergence of new and updated standards (e.g., ISO 10993-18:2020) also introduces more rigorous testing regimes that will increase cost and time commitments for new medical device submissions. How these new standards will affect legacy devices is still under scrutiny.

Risk Management

Under MDR Article 10, manufacturers are required to implement a specific risk management system that is both continuous and iterative, including updates during the product life cycle. This system is closely tied with clinical and postmarket surveillance (PMS) and evaluation to keep users informed and updated on any new or identified risks that arise over time.

Under MDR, manufacturers, distributors, and importers are required to implement a comprehensive quality management system (QMS). Most companies can meet this requirement by obtaining ISO 13485:2016 certification; however, compliance to ISO 13485:2016 QMS will not fulfill all the additional PMS requirements in the MDR.

Clinical Evaluation

Manufacturers of medical devices will need to plan, conduct, and document clinical performance and safety testing to demonstrate conformity with the relevant GSPRs in Annex I. This evaluation, and the related documentation, must be updated with postmarket clinical data throughout the life cycle of the device.

In addition, the MDR imposes tighter restrictions on “device equivalency” for purposes of clinical evaluation reports (CER) and summary of safety and clinical performance (SSCP). Review of existing CERs to ensure compliance with the new requirements will be necessary. There are also additional requirements to report specific events to the upcoming EU medical device electronic reporting system (EUDAMED).

Postmarket Safety Surveillance

MDR places greater emphasis on postmarketing activities, requiring organizations to have a PMS system based on a Postmarket Surveillance Plan (PSP). The PSP and PMS documentation are now part of the technical documentation for the device—a significant difference from previous requirements.

Another significant change is that PMS is viewed as a proactive process that requires medical device manufacturers to be fully aware of the performance of their devices in the market. The regulation emphasizes trend-reporting requirements that must be actively monitored and reviewed.

Manufacturers must also prepare a Periodic Safety Update Report (PSUR) for each Class IIa, Class IIb, and Class III device. PSURs will need to be updated at least annually (for Class IIb and Class III devices) or every two years (for Class IIa devices) and be maintained as part of the device’s technical documentation. Class III devices will also need to submit the PSUR to the Notified Body for review via EUDAMED. Manufacturers of all classes of medical devices will also need to submit vigilance and PMS reports to the upcoming EUDAMED.

How Exponent Can Help – Technical and Regulatory Support for All Stages of Device Certification

  • Exponent leverages a thorough understanding of regulatory requirements and a long history of interaction with the medical device industry to support the development, update, and internal audit of technical file documentation.

  • Our multi-disciplinary teams can develop experimental design and testing protocols for gaps identified in verification and validation testing.

  • Exponent’s technical experts have the experience to create, review, and update existing CERs through systematic literature reviews and statistical analyses of clinical performance data.

  • Exponent’s engineers and scientists can provide support to all aspects of PMS restructuring, including clinical study design, complaint handing, and data analysis, as well as development of a proactive PMS infrastructure.

  • Exponent's team of epidemiologists, statisticians, and clinical research scientists can assist in clinical performance trend reporting and statistical analyses required as part of the PMS activities.

  • Exponent can develop audit-ready proactive trend reporting mechanisms and assist with corrective and preventative actions.

Professionals

News & Events