Conformity assessment procedure: approval for medical devices
Medical devices and in vitro diagnostics (IVDs) are subject to a range of varyingly complex conformity assessment procedures depending on their classification. All of them end with a manufacturer’s declaration of conformity – and the authorisation to market a product with a CE mark.
Diapharm supports manufacturers during this “approval” process for medical devices and IVDs. We help manage the project planning and realisation, plus we draft all necessary documents and/or evaluate existing documentation. Diapharm also supports clients when it comes to communicating with the agencies and authorities in charge of conformity assessment procedures and in resolving differences of opinion.
Involvement of a notified body
A notified body must be involved in the conformity assessment procedure for medical devices (risk classes Is, Im, IIa, IIb, and III) and IVDs in accordance with Annex II of Directive 98/79/EC. We coordinate the approval process with the notified body on our clients’ behalf.
Diapharm provides support and advice for the consultation procedures with the EMA or the national regulatory authorities for medical devices that feature ancillary medicinal modes of action. Our expert teams for medicinal products and medical devices work closely together to prepare dossiers for such combination products and provide support throughout all the necessary pre-submission or scientific advice meetings