We are committed to responsibility ...
We can assume complete regulatory responsibility for the marketing of medical devices and in vitro diagnostics (IVDs) on behalf of our clients.
... as a manufacturer
Diapharm can act as the formal manufacturer of a medical device or IVD if the marketing company and contract manufacturer are unable or unwilling to do so. Based on our ISO 13485 certification, we complete the conformity assessment procedure – including an audit by the notified body – and ensure continous product maintenance.
We are legal manufacturer of 31.000.000 packs of medical devices currently on the market in Europe. This allows clients to focus on what they do best, such as product development or marketing.
... as an OEM or PLM
The relationship between an OEM and a PLM is a special element to consider when it comes to product responsibility. The Original Equipment Manufacturer (OEM) develops the product, completes the conformity assessment procedure and maintains the necessary documents. After that, the Private Label Manufacturer (PLM) adopts the finished product and acts as the manufacturer as defined in Directives 93/42/EEC (medical devices) and 98/79/EC (IVDs).
In its role as an OEM, Diapharm develops medical devices and IVDs on behalf of clients and helps get them marketable. Clients can out-license such products to marketing companies, which then act as the PLM. Our clients maintain the intellectual property rights to the product in this scenario.
In other cases, OEMs that develop medical devices and IVDs use Diapharm as a PLM. This allows them to offer other companies co-marketing rights with a neutral brand and manufacturer name. Combinations of both scenarios are also possible.
The products are always marketed in the name and corporate identity of the client or the licensee or marketing partner.
… as an authorised representative
Diapharm can act as an authorised representative in accordance with Directive 93/42/EEC (medical devices) or 98/79/EC (IVDs) on behalf of companies based outside the European Economic Area. The services Diapharm offers go well beyond the requirements for an authorised representative.