What are Common Specifications?
The definition of common specifications according to the EU MDR and IVDR is “ set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system”.
The concept of common specifications is explained in the Article IX of EU MDR:
[….], where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG (Medical Device Coordination Group), may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV.
In fact the common specification can address different topics linked to the EU MDR, such as:
- general safety and performance requirements (set out in Annex I),
- technical documentation (set out in Annexes II and III),
- clinical evaluation and post-market clinical follow-up for medical devices (set out in Annex XIV of the MDR),
- performance evaluation and post market performance follow-up for IVDs (set out in Annex XIII of the IVDR),
- requirements for clinical investigation for medical devices (set out in Annex XV of the MDR), or
- requirements for performance studies for IVDs (set out in Annex XIII of the IVDR).
Basically the typical way to prove compliance to the requirements of EU MDR is to follow a specific ISO standard. However, when ISO standards do not exist or are insufficient to cover the requirements of the EU MDR, then Common Specifications are developed.
Common specifications will be adopted by the Commission, after consultation with the Medical Devices Coordination Group (MDCG), which is the organism responsible for the dveleopment of guidelines to support the implementation of the EU MDR .
Devices that are in conformity with the Common Specifications (CS) shall be considered in compliance with the requirements of the EU MDR covered by the specific common specifications.
Common specification shall be used when harmonized standards used to support compliance to the EU Medical Device Regulation do not exist or ar insufficient
The use of common specifications will most likely be in two circumstances:
- to assess clinical evaluation and risk management associated with the safety of devices absent a medical purpose
- to establish requirements for validation, risk management, testing, and reporting of incidents associated with reprocessing single-use devices within health institutes.
Common Specifications for Reprocessable Devices
The first common specifications to be established by the commission were the ones for the reprocessing of single-use medical devices (SUDs). This guidelines provides instructions on the regulatory compliance for reprocessable device, including:
- risk management, including consideration on the analysis of the construction and material, the preliminary assessment of the suitability of a single-use device for reprocessing, the monitoring of changes made by the manufacturer of the original device and the maximum number of reprocessing cycles;
- the validation of procedures for the entire process of reprocessing, including cleaning steps, the monitoring of sterilization cycles;
- the quality management system, including an annual audit, the collection of information regarding serious incidents arising in connection with reprocessed device, as well as the reporting of incidents involving devices that have been reprocessed;
- the traceability of the reprocessed single-use devices: tracking of reprocessing cycles and maintaining records of all the reprocessing process steps.
Conclusions
In conclusions, in this article we have been going through the concept of Common Specifications around the EU MDR 2017/745. We explained what common specifications are and we discussed about the first common specifications defined by European Commission on the reprocessing of medical devices.
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