Medtec Insight – Pharma Intelligence I Informa
By Sarah Sorrel
More EU Clinical Data Requirements Coming With New Regulations
IN THE EU, A TWO-STEP STRENGTHENING of requirements for clinical data means manufacturers and notified bodies need to act now, well ahead of the new Medical Device Regulations taking effect. Sarah Sorrel, president of device clinical research organization Medpass International, explains how and why in this guest column. Regulations…
Two major steps toward the tightening of clinical data requirements for CE-marking were made this summer. The first was the June publication of the EU guidelines on Clinical Evaluation, MEDDEV 2.7.1, Revision 4. The second was public release the same month of the next of the new Medical Device Regulation, which is expected to be voted on by the European Parliament in early 2017.
Clinical evaluation reports that are now in development need to meet the new requirements.
The documents are supposedly separate and the latest MEDDEV version technically applies to the current EU regulation scheme under the Medical Devices Directive. But the new MEDDEV guidelines also usher in certain aspects of the future Medical Device Regulation, especially relating to the use of equivalence to waive the need for pre-market clinical investigations.
In light of these developments, manufacturers need to make plans now to ensure their devices will meet all the new requirements in a timely manner.
MEDDEV 2.7.1, Revision 4, immediately applies to clinical evaluations of all medical devices, regardless of classification. Therefore, clinical evaluation reports (CERs) that are now in development need to meet the new requirements, and CERs presented to support re-certification of CE-marked devices already on the market will also need to be updated as laid oud in the guidelines.
This also means that post-market clinical follow-up programs that are currently in progress should be reevaluated to ensue they will provide the clinical data needed to meet the new requirements…