The Medical Device Coordination Group (MDCG) has recently published several interesting guidelines for the medical and in vitro diagnostic Medical Devices fields.
The MDCG 2020-5 “Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies” guideline aims to underline the differences between the MDR and the guide MEDDEV 2.7 / 1 rev.4 with regard to criteria that have to be fulfilled for the demonstration of equivalence. The differences concern technical, biological and clinical characteristics. The equivalence has to be demonstrated according to the MDR requirements and the relevant documentation has to be included within the clinical evaluation report.
The MDCG 2020-6 “Regulation (EU) 2017/745: Clinical evidence needed for Medical Devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies” guideline provides information on the necessary clinical data and evidences sufficient to demonstrate the conformity with the relevant General Safety and Performance Requirements (GSPR) (article 61 MDR) for the legacy devices, carrying the 93/42/CEE (MDD) or 90/385/CEE (AIMDD) CE mark. The document includes information for Manufacturers and Notified Bodies to carry out the conformity assessment procedure and the clinical investigations according to article 61 of the MDR. With regard to the 93/42/CEE and 90/385/CEE Directives, the MDR provides further details and indicates a series of important factors for the clinical evaluation process.
In the MDCG 2020-7 “Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies” guideline, the attention is placed on the development of a post-marketing clinical follow-up plan (PMCF) required by the MDR.
The PMCF plan in part of the post-market surveillance plan. The Manufacturer, after making the analysis, has to document the results in a PMCF evaluation report. This report has to be included in the Clinical Evaluation Report and in the Technical Documentation and it can be evaluated by the Notified Body.
The MDCG 2020-8 “Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies” document adds the template of the evaluation report of the PMCF plan to the previous guideline. In order to update the Clinical Evaluation and the Post-Market Surveillance Plan, the conclusions of this report have to be taken into account.
The MDCG 2020-9 “Regulatory Requirements for Ventilators and Related Accessories” guideline shows several normative options to support production and placing on the market of ventilators in the context of COVID-19 pandemia.
For example, according to the derogation procedure contained in the document “Guidance on Medical Devices, active implantable Medical Devices and in vitro diagnostic Medical Devices in the Covid-19 context”, the Competent Authority of the Member State, in the interests of public health, authorizes the placing on the market of the Medical Devices in his territory and he can also arrange their purchase.
https://ec.europa.eu/docsroom/documents/40903 https://ec.europa.eu/docsroom/documents/40904 https://ec.europa.eu/docsroom/documents/40905 https://ec.europa.eu/docsroom/documents/40906 https://ec.europa.eu/docsroom/documents/40941 https://ec.europa.eu/docsroom/documents/40607