Leading international life sciences consulting firm, Maetrics, is making available a free guide for Medical Device manufacturers in the hope of helping them keep across the thorny problem of how to create and manage their Clinical Evaluation Reports, a key European regulatory requirement.
Background
Medical Device manufacturers have been trying to solve the riddle for years: although every medical device sold into Europe must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File the industry is still confused as to what the report should contain, how to set it out and what the standard for clinical data should be.
The result is that standards vary massively and put businesses at serious risk. Indeed the 2007 amendment to the Medical Device Directive (MDD) did little to clarify this issue and subsequent scandals such as Poly Implant Prosthese(PIP) breast implants have put increased pressure on Notified Bodies to be more rigorous and transparent in their handling of CERs. The issue can only become thornier with the introduction of the new Medical Device Regulation (MDR) so manufacturers are rightly revisiting their CERs.
Consulting firm Maetrics has produced a free guide that:
· Gives examples of common 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
The guide is downloadable here
Company comments
Chris Rule, Manager, Solutions Delivery at Maetrics states: “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.”
Source: Maetrics
