After Clinical Data, addressing Post Market Issues is the next most demanding area of the New MDR.
According to Section , Article 83 of the New MDR, the basics of a PMS process are that it should be;
PLANNED; ESTABLISHED; DOCUMENTED; IMPLEMENTED; MAINTAINED; UPDATED;
and it must be an INTEGRAL PART of the manufacturers QUALITY SYSTEM.
Further, the PMS process must be tailored to "Each Device" or Product Range that the manufacturer places on the market!
Still further, the PMS process must be applied throughout the “entire Lifetime” of the devices in question.
The PMS Plan is part of the PMS process, which in itself is part of the Technical Documentation requirement of Annex II.
A PSUR is necessary for Class IIa devices and higher.
For Class IIb & class III, the PSUR must be updated on an annual basis.
An effective Vigilance System is vitally important and is an Integral part of the PMS process.
It is a Regulatory Requirement and must interface with the Competent Authorities and provide for the issue of FSN's (Field Safety Notices) and FSCA's (Field Safety Corrective Actions).
Whether your PMS process has yet to start......or maybe it has only been operating for a short time......or maybe it is fully compliant with MDD 93/42/EEC, but you just need help and assurance to ensure that you meet the New MDR 2017/745, with its much more stringent application of Post Market Surveillance.....
.....whichever scenario applies or whichever Stage your PMS process is at, we can tailor a Plan to assist you to accomplish your objectives....
Someone will respond to you as soon as possible, usually within 24 hours.
MDRS-EU, ALTRINCHAM, Cheshire WA15 7SN, GB