Role of Medical Device consultant
Medical Device consultants obtaining EU, UK and US certifications!
Medical device consultants play a crucial role in ensuring the safety of medical devices. However, it is important to note that only German medical device law (MPG, MPDG) mandates the position of a "medical device consultant." The EU directives (MDD, IVDD, AIMDD) and EU regulations (MDR, IVDR) do not specifically include this concept.
Manufacturers need to stay updated not only on the changes introduced by the MPDG regarding the role of medical device consultants but also on all regulatory requirements associated with this position. The activities of medical device consultants encompass providing instructions and information to users (experts) regarding the utilization of medical devices. Simultaneously, medical device consultants are obligated to report any issues, risks, and side effects that arise from the use of these devices to the manufacturer.
In addition to the role of medical device consultants, it is worth mentioning that AF Pharma consultants also play a vital role in assisting medical device manufacturers in obtaining various certifications. These certifications include the CE marking, which is required for placing medical devices on the market within the European Economic Area (EEA). AF Pharma consultants possess expertise in navigating the complex regulatory landscape and can guide manufacturers through the necessary processes to achieve CE certification.
Furthermore, AF Pharma consultants also provide support for obtaining the UKCA (UK Conformity Assessed) certification. This certification is specifically required for medical devices intended to be marketed in the United Kingdom following its exit from the European Union.
Moreover, AF Pharma consultants can assist medical device manufacturers in obtaining certifications from the U.S. Food and Drug Administration (FDA). The FDA certification is essential for accessing the U.S. market, which is a significant milestone for manufacturers aiming to reach a global audience.
By engaging AF Pharma consultants, medical device manufacturers can benefit from their specialized knowledge and experience, ensuring compliance with regulatory requirements and increasing the chances of successfully obtaining CE, UKCA, and FDA certifications.