Service for medical devices: approval, maintenance, QM system
Classification, CE marking, technical documentation: Diapharm supports manufacturers of medical devices, combination products and in vitro diagnostic (IVD) medical devices, making their work easier. We are the professional contact for all questions that arise with regard to market requirements, medical devices directives and especially the new EU regulations on medical devices.
Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVD) pose challenges to manufacturers of medical devices and IVDs. Substance-based medical devices, such as lozenges, dermatological products or nasal sprays which have a physical effect, are assigned to a higher risk class under the Medical Devices Regulation. As a result, certification is necessary to ensure their continued marketability. The introduction of classification rules also necessitates the involvement of a notified body for the vast majority of in vitro diagnostic medical devices. A quality management system in accordance with ISO 13485 is required in both cases. We help manufacturers to effectively and efficiently meet the requirements of the Regulations on Medical Devices and IVDs.
We make innovative medical devices a reality
Diapharm is a leading developer and consultant for substance-based medical devices and IVDs in Europe – and one of the most successful for our clients. One reason for this is that we keep an eye on all regulatory and normative requirements from the very start. We perform feasibility tests at an early stage and can draft expert reports on demarcation issues for borderline products. When it comes to these products, it is not immediately apparent whether they are covered by the Medical devices legislation or fall into other categories, such as medicinal products, cosmetics or “lifestyle” tests. We provide support for clinical evaluation as well as for clinical trials that might be necessary with medical devices or for performance evaluations of IVD.
Approval / conformity assessment
Medical devices and IVDs must undergo a conformity assessment procedure, the official name for the marketing authorisation for medical devices, before they can be marketed. We draft the required technical documentation (device master records), ensure correct product labelling, and manage the conformity assessment procedure at the notified body up to the moment when the device or IVD receives a CE mark.
Market launch and quality assurance
If necessary, Diapharm can assume all responsibilities and duties for regulatory and organisational maintenance that manufacturers of medical devices have to fulfil throughout the entire product life cycle. We support companies in developing quality management systems in accordance with ISO 13485, including risk management in accordance with ISO 14971, or provide our own certified quality and risk management system by acting as responsible manufacturer (as defined in the relevant legal framework) or authorised representative. We travel the world to conduct the necessary audits and provide support on regulatory issues to ensure that medical devices and IVDs comply with the constantly evolving regulatory and normative quality, performance, efficacy and safety requirements. In addition, we provide post-market surveillance to ensure the constant monitoring of medical device safety.
Whenever we act as a responsible manufacturer on our clients’ behalf, we manage the entire medical device approval process – and we see it through with the notified body until the device receives a CE mark. We also provide support throughout the consultation procedures required for combination products (medical devices with ancillary medicinal activity).