Novatek's New Clinical Evaluation Report (CER) Solution Helps Clients Meet Approaching EU MDR Deadline
Medical device manufacturers must transition to EU MDR (MEDDEV 2.7/1 Rev 4) by May 2020. Novatek's new CER Solution helps clients develop Clinical Evaluation Reports, SOPs, and IFUs to meet compliance standards.
ROCHESTER, N.Y., June 20, 2019 /PRNewswire-PRWeb/ -- As of May 2020, U.S. medical device manufacturers who sell devices in Europe must comply with tighter, more comprehensive regulations set forth by the European Medical Device Regulation (EU MDR). Novatek Communications now offers a comprehensive Clinical Evaluation Report (CER) solution to help manufacturers transition to the MDR.
The specific guideline, called MEDDEV 2.7/1 Rev 4, mandates the submission of CERs to notified bodies to determine regulatory conformity in advance of authorizing a CE mark. The guideline requires a robust analysis of the safety and performance of the device, as well as requiring research and disclosure of the state-of-the-art for the device, and a full report of post-market surveillance activities.
The regulation applies to all devices, regardless of class, and will be imposed on existing products as well as products in development. According to Dale Canning, Novatek's Director of Operations, "In this changing regulatory environment, training and documentation are at the root of the new compliance standards. CERs are under increased scrutiny, so writing an accurate CER is a critical step. Post-market surveillance is equally important to maintain compliance throughout the life of the device."
Novatek's CEO, Amy Castronova, emphasizes the urgency of meeting the deadline. "With just 11 months to go, it's imperative for medical device companies to act now, but manufacturers may not have internal resources to tackle a CER. With our expertise, Novatek can help identify what's missing, make a plan, and develop the CERs so our clients meet the compliance deadline."
In addition to CERs, Novatek provides medical device product documentation services such as Standard Operating Procedures (SOPs), Instructions for Use (IFUs), and quality systems process documentation.
Learn more about Novatek's EU MDR compliance solution at http://www.novatekcom.com/eu-mdr-compliance.
About Novatek Communications
With over 30 years in business, Novatek Communications, Inc. specializes in technical communications for regulated medical device and manufacturing companies. A full-service documentation and training company, Novatek develops product and process documentation, creates comprehensive training programs, and documents cyber security policies and procedures to help clients meet compliance, manage risk, and get products to market. Learn more at novatekcom.com.
SOURCE Novatek Communications
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