Competence in Regulatory Support and Strategy for Amferia´s Wound Care Product

Purpose and goal

This project was coordinated by Amferia AB and supported by an external regulatory consultant. The goal achieved during the project has been the establishment of a regulatory strategy and a plan to prepare the technical file for Amferia´s wound care product, Ampa. The originally planned objective was to achieve the CE marking of Ampa as a Class 1 product in Europe. However, based on our discussions with notified bodies, we have decided to apply for a Class 2A certification that enables a stronger value for the product and to claim that the product is antimicrobial for hospital applications.

Expected results and effects

Amferia has now established a clear regulatory process forward to obtain CE certification of our wound product. As a result of this project, we have gained direct contact with Notified Bodies and are developing/testing our product according to necessary ISO and production standards. The effect is a documented plan forward in terms of clinical evaluation, production standards and technical file. The aim is to begin product review during Fall 2020 for certification. An example is the initiation of biocompatibility and skin irritation tests as per ISO standards.

Planned approach and implementation

This work was performed by Amferia with a consultant from Mediteq AB. Throughout the work, Amferia and a consultant held two half-day workshops to identify eligibility requirements and legal requirements for Ampa. This also helped identify risk classification, list of notified bodies, identify any critical issues for intended use, necessary quality standards. The consultant also supported Amferia in documentation to submit to notified bodies for preliminary assessment work. In addition, we performed ISO standard testing of the product, necessary for certification.

External links

Homepage of Amferia AB