This week I am in Brussels at an international conference on medical device regulations. The most popular topic of discussion is the new European Medical Device Regulations that was confirmed on May 25 and published on Monday—the first day of the conference.

Reprocessing of medical device was one of the last negotiating points that were discussed before an agreement was confirmed last month. The definition of reprocessing is: “The process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilization and related procedures, as well as testing and restoration of the technical and functional safety of the used device.” After negotiations, the consolidated draft states, “a health institution may vary from the obligations of the manufacturer…when adequate common specifications are in place and appropriate national regulations are in place.” This compromise allows some countries to prohibit reprocessing, while other countries may allow reprocessing if the device has been established as “safe for reprocessing.” It is specified that reprocessor must prove safety and performance of reprocessed devices and the companies must perform both post-market surveillance and the reprocessor has specific labeling requirements, which include removing the name of the of the manufacturer and the original CE Mark. Presumably this will be clarified in a common technical specification (CTS) that is developed by an expert group. The consolidated draft even includes provisions for the possible scenario of not having a CTS approved prior to the end of the 3-year transition period.

Other areas of popular discussion were labeling, post-market surveillance and clinical evaluations. The particular requirements for UDI labeling and the implementation plan remains still uncertain, but post-market surveillance data and clinical evaluations will dramatically change due to implementation of UDI labeling and making the adverse event reporting data publically available on the Eudamed database. For example, adverse event data will now need to be reported within 15 days—instead of 30 days.

Chapter VII of the EMDR appears to be getting the most interest at this stage. Chapter VII includes three sections:

1. Section 1 = Vigilance (Articles 61-66)
2. Section 2 = Market Surveillance (Articles 67-75)

The requirement for reporting adverse events within 15 calendar days of awareness is found in Article 61(1). The regulations are written such that initial reporting with partial information is required with a follow-up completed report when additional information becomes available. This will result in much more reporting of vigilance, because manufacturers will need to make a decision before they have adequate data. Therefore, your future vigilance process will need to report more frequently, more quickly and you will be expected to submit updated reports when information is complete.

In addition to vigilance data, manufacturers will need to provide labeling and a summary of potential adverse events to the public through the Eudamed database. In addition to providing this new information to Eudamed, manufacturers must also update this information annually. Given the difficulties that manufacturers have experienced in updating the GUDID database for UDI information for the US FDA, many are concerned that the Eudamed database implementation will need to be extended beyond the 3-year transition for the regulations.
If you are interested in learning more about the new European Medical Device Regulations, I will be presenting a webinar on this topic next Thursday, June 23:

http://www.medicaldeviceacademy.com/new-european-medical-device-regulations/

source: https://www.linkedin.com/groups/2070960/2070960-6148820038615920643