Legal Role as Manufacturer
Diapharm assumes the role of legal manufacturer in accordance with MDR and IVDR. All products are distributed entirely under the client’s brand and corporate identity — or that of an appointed distributor. The client is responsible for the physical production of the product or may delegate this step to suitable contract manufacturers. The instructions for use and outer packaging display the name and address of HÄLSA Pharma GmbH (HÄLSA); otherwise, the product continues to present itself in the client’s familiar design.
Quality Management Provided by Diapharm
In this setup, Diapharm — or HÄLSA — assumes full manufacturer responsibility, including conformity assessment, product maintenance, oversight of production with batch release for market placement, and a fully certified quality management system. Clients can rely on this system to meet all requirements for an EU-compliant QMS and ISO 13485 certification without having to establish their own.
This means, for example, that pharmaceutical companies do not need to extensively expand or adapt their existing GMP-compliant QM systems for medical devices. Distributors also gain a convenient and secure way to expand their product portfolio to include medical devices and in vitro diagnostics.
Authorized Representative for Medical Devices
For companies based outside the European Economic Area, Diapharm acts as an Authorized Representative for medical devices and in vitro diagnostics (European Authorized Representative; EAR or EC Rep). Likewise, for companies placing medical devices on the market in the United Kingdom or Switzerland, Diapharm serves as the Authorized Representative (UK Rep and/or CH Rep).
Manufacturers without an establishment in the European Union that wish to market medical devices or IVDs in the EEA must appoint an Authorized Representative to act on their behalf. The same applies to manufacturers outside the UK or Switzerland who want to place medical devices on those markets. The EC Rep, UK Rep, and CH Rep support non-EU manufacturers in properly interpreting the applicable regulatory requirements for medical devices and IVDs and act as the point of contact for competent authorities regarding product registration and market surveillance.
Manufacturer-to-Manufacturer Support
Beyond fulfilling the formal role of EC Rep, UK Rep, or CH Rep, Diapharm also answers questions about specific regulatory requirements for medical devices and IVDs in Europe, as well as requirements for product maintenance and post-market surveillance according to EU standards.
