To give you a flavour of some of the worries that current QCS clients have:
- The new Medical Device Regulations
- LRQA and UL abandoning their notified body status
- Only 2 Notified Bodies currently qualified for the full continent of Europe for MDR
- 12- month Lead times for Technical File Examinations
- EUDAMED not completed
- A new draft of ISO 14971 for Risk Management
- no clear scheme for UDI issuance
There has never been time of so much uncertainty regarding device compliance in Europe. This has prompted the FDA to question the wisdom of the MDR implementation timetable scheduled for May 2020 and May 2022 for IVD devices.
Until clear guidance is provided on these issues, at a political level, organisations have a difficult task in place to plan the resource necessary for their compliance.
QCS have their finger on the pulse of the changing regulatory landscape and can provide you with pragmatic advise to help devise your regulatory strategy.