According to Directive 93/42/EEC (MDD) all medical devices have to undergo a clinical evaluation in accordance with Annex X of the MDD. In vitro diagnostics (IVDs) are subject to a performance evaluation. We are here to help.
We support manufacturers of existing medical devices whose conformity assessment was drawn up in accordance with the Medical Devices Directive (93/42/EEC) in maintaining the marketability of their existing products and precisely meeting the requirements of the current Regulation (EU) 2017/745. We review the existing clinical evaluation, prepare a gap analysis, take over the planning and, if desired, even the implementation of any necessary activities. If supplementary clinical data are necessary, a literature search may sometimes be sufficient in accordance with Guideline 2020-16 MDCG. In other cases, data from market monitoring or the collection of new data in vitro or in vivo are required. We have developed efficient processes for this and coordinated them with notified bodies according to MDR.
The format of the clinical evaluation is specified by the guideline MEDDEV 2.7/1 of the European Commission. All available data on the performance and safety of the medical device must be critically evaluated. If necessary, further data must be collected through clinical investigations (studies/testing) in order to fulfil the criteria. These tests must then be carried out in accordance with Art. 61 MDR and taking into account the requirements of ISO 14155.
We actively advise manufacturers on the collection and analysis of the clinical evaluation and on the evaluation of whether clinical trials may be required. For example, it may be sufficient to submit data from in vitro testing rather than a full observational study (AWB) - provided the scientific rationale is well justified. We prepare a Clinical Evaluation Report (CER) documenting the results of the clinical evaluation for your medical device. For combination products consisting of a medical device and a medicinal product, we also provide support in questions of pharmacology.
For in vitro diagnostics (IVD), a so-called performance evaluation according to IVDR must be carried out analogously. For IVDs, too, a clinical evaluation may be required as part of the performance evaluation test. Here, too, Diapharm is a successful and experienced partner of the industry.
Medical devices are also subject to an evaluation of biocompatibility in accordance with ISO 10993 as part of the clinical evaluation. Diapharm works with qualified test laboratories to perform the necessary biocompatibility tests depending on the medical device’s risk class. We consult a toxicologist to verify test plans. We summarise the results of the biocompatibility assessment in a Biological Evaluation Report (BER) ready for submission.