Arguably, two major incentives of revising the EU Medical Device Directive (MDD) with the upcoming Medical Device Regulation (MDR), are the need to extend the scope to include cosmetic/aesthetic devices, and to increase the attention to Post Market Surveillance (PMS). The infamous backstory to the need to revise regulations is the “PIP Breast Implant Scandal”, where an EU based company sold over 2 million breast implants that had an unusually high rate of rupturing and were filled with non-medical grade silicon - causing health problems to many of those affected. As a side note, there are some that question the need to update the MDD in general - as they find that there was not a lack of regulations but rather a lack of enforcement, as Prof. Dr. Christian Johner of the Johner Institute argues in his video.
In the EU MDD (Medical Device Directive), Post Market Surveillance (PMS), was not defined. It was however later covered in the Co-ordination of Notified Bodies Medical Devices NB-Med/2.12/Rec1/Rev 11 - where it is written that “Manufacturers must have an appropriate system for gaining and reviewing experience in the post production phase from the range of devices he manufactures. Notified Bodies have to audit/verify that there is an effective system in place.“ This means that under current regulation, companies have only to demonstrate that they have a system to collect data in a passive way - and most would agree that Notified Bodies have not prioritised this highly when auditing companies.
On May 26, the EU MDR (Medical Device Regulation) will become the law of the land in European Economic Area (EEA = EU + EFTA) and replace both the MDD as well as AIMDD (Active Implantable Medical Device Directive). In it, Chapter VII, Section 1 (Articles §83-§86) covers PMS and defines it as “… all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions”.
This means that companies not only have to demonstrate that they have a system to collect data in a passive way, but also need to have an active system in place which gathers data from different sources, e.g.:
Expert user groups (aka focus groups),
Customer surveys, feedback, complaints, and warranty claims,
Device tracking and implant registries,
Post CE-Mark trials, such as during Post-Market Clinical Follow-Up (PMCF). During PMCF, the manufacturer will proactively collect and evaluate clinical data. PMCF is performed per a plan.
Media, literature reviews, experience with similar devices
Depending on the Class of your device, there are different requirements in regards to frequency of reporting, content, and recipient of information. To see what your company needs to deliver, you might find our PMS Route tool useful.
Xybel is developing a SaaS tool to facilitate the collection of data and creation of PMS plan, PMSR, and PSUR. Please contact us if you are interested in providing feedback for the development of this tool at info@xybel.com.