Post Market issues

The Requirements are set out in Annex III of the New MDR (EU) 2017/745

After Clinical Data, addressing Post Market Issues is the next most demanding area of the New MDR.  

Articles 83 to 86 specify the detail of the requirements

According to Section [1], 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.  

A Post Market Surveillance Plan is required

The PMS Plan is part of the PMS process, which in  itself is part of the Technical Documentation requirement of Annex II.

Periodic Safety Update Reports (PSUR's) may be necessary

A PSUR is necessary for Class IIa devices and higher.

For Class IIb & class III, the PSUR must be updated on an annual basis.

Vigilance is part of the Post Market Issues process

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).

Whatever Stage your PMS process is at, we can help you...

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....

absolute confidence is assured, at every stage of an enquiry

Please contact us for a Quotation in absolute confidence

Thank you for your interest in our Services....

Someone will respond to you as soon as possible, usually within 24 hours.

Medical Device Regulatory Solutions

MDRS-EU, ALTRINCHAM, Cheshire WA15 7SN, GB

0161 870 6751