Post-Market Surveillance as a service for medical device industry
Biocodex’s Pharmaceutical and Medical Services division, PhaMe has set to help companies in medical device industry to overcome the heavy burden of Post-Market Surveillance requirements.
The company has incorporated EU Medical Device Regulation’s Post Market Surveillance requirements into its monitoring system and will be offering it as a service.
New EU MDR Post-Marketing Surveillance (PMS) requirements coming into effect
On May 26, 2021 EU’s Medical Device Regulation (MDR) comes into full force marking a new chapter in Post-Market Surveillance for companies.
MDR does not only require specific Post Market Surveillance activities to be done, but it even requires some of these tasks to be done in a proactive manner.
“In directive era, Post Market Surveillance activities were mostly seen as something you do reactively, like handling your incoming product feedback, whereas in regulation era you have to pull information from several sources”, explains Susanna Heinonen, Head of Pharmacovigilance at Biocodex Phame.
MDR lays ground for Proactive Post-Market Surveillance
Medical Device Regulation defines that Post-Market Surveillance activities shall be carried out proactively to collect and review experience gained from devices placed on the market.
In addition to PMS activities carried out for own products, regulations states that this proactive approach to collect and review information shall allow a comparison to be made between your own device and similar products available on the market.
What public information sources to utilize?
Luckily, MDR lists the minimum set of information sources from where the required PMS data, for your own and similar device, shall be derived from. These sources are
- databases and
In addition, it is required to perform legislative monitoring i.e. proactively monitor changes in an applicable legislative framework.
Biocodex Phame’s Post-Market Surveillance service
Biocodex’s Pharmaceutical and Medical Services division, PhaMe has created a solution to help companies in medical device industry to overcome the heavy burden of new Post-Market Surveillance requirements. The Division has incorporated MDR Post Market Surveillance requirements into its monitoring system and will be offering it as a service.
The system can automatically follow any wanted Post Market Surveillance data sources 24/7 and is also capable of feeding information in to reports like Periodic Safety Update Report (PSUR). The system works through curated groups so it can repeat your literature review inclusion and exclusion criteria or any other criteria you have defined in your PMS Plan or PMS Clinical Follow-Up Plan.
With Biocodex Post Market Surveillance as a service, companies can rely on their Post Market Surveillance activities are done in a compliant and efficient manner right from the MDR date of application, May 26, 2021.
Please do not hesitate to contact Susanna Heinonen for more information.