In a bid to help clarify the all-but-transparent requirements needed to produce a compliant Clinical Evaluation Report (CER), Maetrics has drafted a free go-to guide for Medical Device manufacturers downloadable here: http://www.maetrics.co.uk/white-papers/uncategorized/clinical-evaluation-of-medical-devices.
Every medical device sold into Europe, irrespective of its classification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File, but guidance, specifically around clinical data, is unclear and not comprehensive enough, resulting in confusion that was only partly assuaged by the 2007 amendment to the Medical Device Directive (MDD).
In addition to this, scandals such as Poly Implant Prostheses’ use of cheaper, industrial-grade silicone in breast implants and toxic debris from metal-on-metal hip implants, have cast the issue of Medical Device compliance very much into the public eye. Notified Bodies and their handling of CERs are therefore coming under increasing scrutiny, which will further intensify with the introduction of the new Medical Device Regulation (MDR). As a result, manufacturers are wisely running for cover and revisiting their CERs.
To support them, Chris Rule, Manager, Solutions Delivery at Maetrics, provides a must-read step-by-step guide to compliance that:
• Highlights common sources of non-compliance
• Addresses gaps in clinical evaluation guidance
• Clearly sets out the clinical evaluation process
• Clarifies CER requirements with a simple check-list
• Helps manufacturers attain compliance and prepare for future regulatory changes
Providing a key element in the arsenal of any compliant Medical Device manufacturer, this is soon to become the go-to guide on producing compliant CERs and protecting users firm from the consequences of non-compliance.
Chris Rule comments: “Our aim with this guide is to help Medical Device manufacturers find their way through a complex and unclear regulatory environment and produce CERs that they are confident will pass the test. In order to do this, the white paper clearly and simply defines the main requirements, explains how to set out a successful CER and analyses some of the mistakes that are typically made.
“Slip ups can be expensive and time consuming, but most of all they can seriously damage your business, so it is vital for firms to ensure that they are well prepared to face inspections and reviews of their Technical Files at any time. Keeping these items up to scratch is an ongoing process that will ensure a business can easily and rapidly become compliant when regulatory changes do occur.”