April 23rd and 24th, 2020, the Medical Device Coordination Group (MDCG) released five new guidance documents. The new guidance documents offer device firms and notified bodies more details on demonstrating equivalence to existing devices, clinical evidence for legacy devices, templates for post-market clinical follow-up plans and evaluation reports and regulatory requirements for ventilators.
New: MDCG 2020-5 Clinical Evaluation – Equivalence.
MDR states in Article 2 (48) that clinical data can, among others, be sourced from:
- clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated.
- reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated.
In Annex XIV Part A (3) MDR states that a clinical evaluation may be based on clinical data relating to a device for which equivalence can be demonstrated and what considerations should be made when demonstrating such equivalence.
The MDCG explains that the MDR requires that technical, biological and clinical characteristics are considered when demonstrating equivalence to another device. Whilst these general characteristics are described in the MEDDEV 2.7/1 rev. 4 Appendix 1 and are aligned with the MDR requirement, there are differences in the criteria that are set out for each of the three characteristics.
The document contains an Equivalence Table, for manufacturers to fill in to compare a device with a presumed equivalent marketed device.
New: MDCG 2020-6 Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC.
The aim of the new guidance is to explain how to generate sufficient clinical evidence to demonstrate conformity to the relevant general safety and performance requirements (GSPR) for “legacy devices”. In this document legacy devices are defined as “all devices previously CE marked under the European Medical Devices Directive 93/42/EEC (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).” This definition does not include a minimum time under which such devices have been made available on the EU market under these Directives. Thus, all device, whether placed on the market the day before or years before the Date of Application of the MDR, are considered legacy devices.
The guidance states that sufficient clinical evidence should be understood as “the present result of the qualified assessment which has reached the conclusion that the device is safe and achieves the intended benefits.” It re-emphasises that clinical evaluation is a process where this qualified assessment must be done on a continuous basis.
The guidance goes on to provide specific recommendations for conducting clinical evaluations for legacy devices in accordance with Annex XIV Part A of the MDR.
New: MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template.
New: MDCG 2020-8 Post-market clinical follow-up (PMCF) Plan Template.
In two separate guidance documents, the MDCG provides templates for a post-market clinical follow-up plan and a post-market clinical follow-up evaluation report.
New: MDCG 2020-9 Regulatory requirements for ventilators and Related accesories.
In the MDCG guidance on ventilators and related accessories, the different regulatory options are explained for bringing devices to market in order to facilitate the swift entry of the much-needed devices amid the coronavirus disease (COVID-19) pandemic.
What does this mean to you?
Manufacturers of Medical devices should start familiarising themselves with these new MDCG guidance documents.
Will you utilise clinical data based on equivalence claims? Then carefully assess if indeed equivalence can be claimed in accordance with the requirements stipulated in the MDR.
Do you have “legacy devices” CE marked under the MDD and AIMDD? Then it will be wise to assess if the clinical data you have at hand provides “sufficient clinical evidence” to demonstrate conformity with the relevant General Safety and Performance Requirements in the MDR for legacy devices.
And finally incorporate the PMCF Plan and Evaluation Report templates into your company templates.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.