The new Medical Devices Regulation (EU-MDR) brings a number of significant changes, putting pressure on all impacted parties to closely examine the Regulation, assess the impact it will have on their own organization, and implement compliant processes and procedures accordingly.

Since MDR’s release in 2017, many regulatory experts have published and circulated resources aimed at helping companies understand the new rules and adjust their organizations accordingly. While many of these resources are extremely useful, we set out to offer a tangible, step-by-step guide that can be adapted to fit the needs of many companies. 

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With the clock ticking toward 2020, MDR transition should be a high priority for device companies currently marketing products—or planning to market products—in the EU. Due to  significant changes in the forthcoming Regulation versus the MDD, this transition process should begin with a comprehensive gap assessment led by experienced compliance experts who know exactly what to look for.

Since the MDR does not grandfather legacy products and presents limited allowance on the short-term continuation of supplies to the EU market following the formal transition, portfolio revision and a global impact assessment will also be needed for many organizations.

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Some of the most significant regulatory changes affect clinical evaluation for devices. Perhaps the most fundamental of these changes is the inclusion of a definition for the term itself—something not provided in the MDD.

According to the MDR, a clinical evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer.

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The US Food and Drug Administration (FDA) recently finalized a rule requiring medical device clinical investigations conducted outside the United States to conform to standards for good clinical practice (GCP).

The agency defined these practices as "a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected."

FDA notes that the final rule "does not identify a specific GCP standard for sponsors and applicants to follow. Instead, the rule includes a definition of GCP in § 812.28(a)(1), which is consistent with the definition in § 312.120 (21 CFR 312.120), that embodies well recognized GCP principles and has been generally accepted. This allows sponsors of clinical investigations conducted outside the United States to determine an appropriate GCP standard to use for clinical investigations that will produce data to support an IDE or a device marketing application or submission to FDA."

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A new report from PricewaterhouseCoopers (PwC), showed a spike in CDER warning letters in 2017 as pharmaceutical companies struggled to maintain quality control in light of greater regulatory oversight over quality at manufacturing sites.

While 22 percent fewer warning letters were issued by FDA overall in 2017 from 2016, those from CDER increased by 35 percent, totaling 85.

Digging deeper into the contents of these warning letters, data integrity issues and non-adherence to current Good Manufacturing Practices (cGMP) were cited as common root causes.

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