Post Market Surveillance (PMS)

Q: How does the European medical devices regulation (MDR 2017/745) impact CER requirements?

The MDR 2017/745 and revised CER guidance (MEDDEV 2.7/1 rev 4) both reflect more stringent requirements for clinical data and post-market requirements, highlighting the importance of ensuring your documentation is all in order. You will also need to update your CER on an annual basis. So get in touch with our team if you would like any additional support on this

Under EU MDR, manufacturers must monitor and evaluate device safety and performance post-market through a structured Post Market Surveillance (PMS) system.

PMS includes planning, implementation, reporting, and regular updates for every medical device

Get In Touch

FAQs on Clinical and Post-Market

Two diverse businesspeople smiling while working on a laptop together at the end of a boardroom table in an office

Trusted by top-tier teams worldwide

Multi-ethnic business people smiling during a meeting in conference room. Team of professionals having meeting in boardroom.

Apotech can support with:

PMS plan and report development
Post Market Clinical Follow-Up (PMCF) plan and report
Vigilance systems
Periodic Safety Update Reports (PSURs)
Complaint and adverse event handling
Risk management integration
Field Safety Corrective Actions (FSCAs)

FAQs on MedTech clinical and post-market services

At Apotech, we aim to make our MedTech clinical and post-market services as simple to understand as possible, which is why we’re always on hand to answer any questions you might have.

Here are some of the questions we get asked most often.

How does the European medical devices regulation (MDR 2017/745) impact CER requirements?

Featured case studies

Software as a medical device (SaMD)

Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regulatory affairs Responsible person FSP Scope of work Our client recently partnered with groups of clinics in the United Kingdom and therefore asked us to act as their UK…

QMS Implementation for Class III Medical Device

QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innovative start up, which has developed a best-in-class pacemaker. At the time of engaging with them they were on the road to CE Marking. Apotech Team Worked full time on the project: balanced…

Borderline device classification

Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…

View all case studies

Ready to get started?

Get in touch