The EU MDR and eu DVVI will be fully applicable in EU Member States from 26 May 2021 and 2022, but the devices can already be put on the market under these new rules (if they are fully compliant with the new rules). A new document – Effective Field Safety Codes (NSF): Guidelines for Medical Device Manufacturers Medical device monitoring provisions are complemented by general surveillance guidelines to facilitate and harmonize the transposition of EU directives on medical devices by manufacturers and relevant authorities. New European Commission briefing paper on reporting incidents involving electronic cardio-active devices equipped with cardiac cardio-active devices The new rules strengthen manufacturers` requirements for post-market surveillance. The amendments that affect what needs to be communicated to the MHRA and, if so, provide for stricter time frames for manufacturers to report adverse events, implement periodic update reports (PSRRs) and extend the definition of a medical device to test other products. The application of harmonised legislation on medical devices is the responsibility of the authorities of the EU Member States. An important aspect of the medical device industry is the guarantee of product safety. To this end, monitoring and vigilance of this sector are essential. Read the European Commission`s detailed instructions on what information to report, how and when an adverse incident should be reported to the MHRA, and also read the additional guidelines that you should also read below regarding information to account for certain types of devices. You must report any adverse incidents with your medical device to the appropriate authority where the incident occurred. Eudamed2 is the European database on medical devices. According to CEP module I1; The collection, treatment and management of individual case safety reports (ICSRs) is a critical pharmacovigilance process. It is therefore essential that this be included in the VPA.
In this section, there are important areas that need to be covered. First, the nature of the cases covered by each partner (for example. B post-marketing, clinical studies, registries, market research) must be defined and whether serious or non-serious cases should be exchanged. It is also necessary to define which party is responsible in which area. Similarly, specific situations and expectations about the perception of cases related to these cases need to be clearly defined. All of this is important to ensure that no source of security data is overlooked and, conversely, that there is no duplication of seizures.