At Azierta,we are specialists in Surveillance at the level of medicines, medical devices and cosmetics, and we are experts in the development of safety reports. We have a validated adverse reaction management software that is 100% aligned with the latest EMA requirements and incorporates modules for medical devices and cosmetics. Most importantly, we have a team of professionals with extensive experience at the service of our clients. For more information see our Pharmacovigilance & Safety website.
The entry into force of the new regulations for medical devices MDR (2017/745) and in vitroproducts IVDR (2017/746) implies new requirements and obligations for medical device manufacturers. In terms of safety, one of the most significant is the need to develop a post-market monitoring plan and periodic safety reports (PSUR), described in Chapter VII of the MDR and IVDR regulations.
Both the post-market monitoring plan and the periodic reports (PSUR) will be mandatory for manufacturers and will be audited by the notified bodies during the certification and monitoring audits. The periodicity for updating the safety report (PSUR) will be annual for IVDR Class, llb and lll medical devices and Class D products, while for IVDR Class IIa and Class C products they will be sent every two (2) years. In addition, for MDR Class III and IVDR Class D products it requires that the report be communicated using the EUDAMED electronic system.
In addition, for MDR Class I products and IVDR Class A and B products, manufacturers shall prepare a Post-Marketing Monitoring Report (PMS), which shall be updated as necessary and/or when requested by the competent authority. These post-market monitoring reports shall include available data relating to:
- Serious incidents and safety corrective actions, (FSCA).
- Non-serious incidents and data on undesirable side effects.
- Information on trend reports.
- Information, including comments and complaints, submitted by distribution users and importers.
- Public information on similar medical devices.
This involves manufacturers searching for information in the national competent authorities' incident and adverse effect reporting databases and producing a report that assesses it:
- Improve the determination of the risk-benefit ratio and the risk management of your products.
- Update design and manufacturing information, instructions for use and labelling.
- Update clinical evaluation.
- Update the clinical safety and performance summary.
- Detect needs for preventive, corrective or safety corrective actions.
- Identify opportunities to improve product use, performance and safety.
- Contribute, where appropriate, to the post-marketing follow-up of other products.
- Detecting and reporting incident trends.
Since the transposition into Spanish law of the European Directive on the safety of cosmetics, the notification of serious adverse effects produced by cosmetics became a mandatory act for health professionals. Cosmetovigilance is aimed at collecting, evaluating and monitoring information on undesirable effects observed as a result of normal or reasonably foreseeable use of cosmetic products.
Regulation 1223/2009 on cosmetic products provides in its Article 23 that responsible persons and distributors of cosmetic products have an obligation to notify all serious undesirable effects related to the use of cosmetic products of which they are aware. This notification should be addressed to the competent authority of the Member State where the said effects occurred.
Furthermore, Article 10 of Royal Decree 85/2018 provides that doctors, pharmacists, dentists, nurses and other health professionals must notify serious undesirable effects of which they are aware and which may have been caused by cosmetic products.
Consumers and professionals using or applying cosmetic products may voluntarily notify unwanted effects.
In addition, both responsible persons and distributors, as well as health professionals, may voluntarily notify undesirable effects related to the use of cosmetic products which do not meet the seriousness criteria.