E-ssentials medical devices, Edition 4, October 2015
The innovative strength shown by manufacturers is setting the pace in the medical device industry – but also for us as service providers. Our colleagues are always one step ahead of even the most rapid developments – and among them is Dr. Bassil Akra, Head of our Clinical Focus Team, who recently received the Innovation Award for his groundbreaking scheme of testing and inspection to accompany clinical studies in progress.
A further innovation from our company is the issue of forgery-proof certificates with hologram and QR code. We also report on the progress being made in the European Medical Device Regulation (MDR), the In vitro Diagnostics Regulation and the multinational Medical Device Single Audit Program (MDSAP), on the new Guides from the Notified Bodies Operation Group (NBOG) and on the exemption from 510(k) clearance for numerous low-risk medical devices.
Our newsletter informs you today of the issues impacting on our industry tomorrow. We hope you enjoy reading it!
Dr. Peter Havel
Senior Vice-President, Medical & Health Services Global
Foreshadowing the new MDR
The revised Medical Device Directive (MDD) is nearing completionas a Medical Device Regulation (MDR). After its reading vote in the European Parliament the draft by the European Commission has now also passed the amendments stage with the European Council. What may change for manufacturers and Notified Bodies?
Council of the EU publishes comments on draft IVD Regulation
The legislative process concerning the Regulation of the European Parliament and of the Council on in-vitro diagnostic medical devices is now gaining momentum.The amendments proposed by the Council are numerous and to some extent very detailed. Read here, what manufacturers have to know.
Taking stock of the MDSAP
The Medical Device Single Audit Program (MDSAP) of the International Medical Device Regulators Forum (IMDRF) moved into its pilot phase on January 1, 2014. After over a year the initiators and participants, in addition to auditing organizations and manufacturers, have now met for an exchange of experience. Read more about the learned lessons.
Clinical Focus Team wins 2014 Innovation Award
TÜV SÜD presented the 2014 Innovation Award to the Clinical Focus Team in recognition of its services. In the interview head of the team, Dr Bassil Akra, a dynamic visionary, introduces himself and his approach to successful clinical strategies. Click here to the interview.
The FDA plans to apply exemptions from the requirement of 510(k) Premarket Notification to specific nonclassified medical devices and some class I and II devices. Read here which devices are effected.
New guidance documents from NBOG
The NBOG published new Best Practice Guides. Two topics are the renewal of EC product certification and the reporting requirements for substantial changes. What that means for manufacturers? Go for information here.