adaptation to mdr
ARE YOU READY FOR NEW REGULATIONS TO KEEP YOUR MEDICAL DEVICES ON THE MARKET?
We know that adapting medical devices to new regulations requires time,
resources and specialist knowledge,
which is why we offer support to your company during the change process.
Trust the experience of Gofarm and entrust the work on your product to our specialists.
You can be confident that everything will run smoothly, on schedule
and in accordance with current regulations.
ARE YOU READY FOR NEW REGULATIONS
TO KEEP YOUR PRODUCTS ON THE MARKET?
GET READY FOR CHANGE TODAY!
DON’T WAIT TILL THE VERY LAST MINUTE!
REMEMBER THAT IT IS THE RESPONSIBILITY OF EVERY MANUFACTURER AND DISTRIBUTOR TO MAKE CERTAIN CHANGES TO THE MEDICAL DEVICE DOCUMENTATION.
Adjustment of medical devices according to the new MDR rules
- Development of technical product documentation according to MDR requirements for all product classes
- Reviewing existing documentation to meet the requirements of changing legislation, including clinical assessment
- Assistance in choosing a notified body
- Development of post-market clinical follow-up plans (PMFC)
- Preparation of summaries of safety and clinical performance (SSCP)
- Development/updating of post-market surveillance plans (PMS)
- Post-marketing document surveillance
- Production/updating of periodic safety update reports (PSUR) and post-market surveillance reports (PMSR)
- Provision of a person responsible for regulatory compliance
- Support at every stage of change
PLEASE NOTE!
THE PROCESS OF BRINGING MEDICAL DEVICES INTO COMPLIANCE WITH THE MDR TAKES TIME AND OFTEN INVOLVES THE PARTICIPATION OF NOTIFIED BODIES.
TAKE THIS INTO ACCOUNT WHEN PLANNING TO IMPLEMENT CHANGES.
WE WILL HELP YOU
The aforementioned services are conducted on the basis of the following legal basis: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC