You can regularly read about an evaluation of the deficiencies in FDA warning letters concerning medical devices. Find out what the past fiscal year looked like in terms of FDA Warning Letters regarding medical devices and what changed compared to fiscal year 2017.
With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.
At what point is a medical device considered a medical device in Europe? So-called borderline products sometimes cause problems regarding classification; a guideline on Borderline products by the European Union may be of help.
The overall responsibility for clinical trials lies with the sponsor. Whereas activities may be contracted or delegated, responsibility itself can not. Read more about metrics and case studies from GCP inspections with regard to sponsor oversight of clinical trials.
The MHRA released a joint statement setting out the legal and ethical requirements for documenting consent using electronic methods. Read more about the MHRA´s view of seeking consent electronically (eConsent).