Are you aware of Common Specifications and their role in the medical devices regulations?

Common Specifications introduced in the European regulatory scheme for medical devices and IVDs

A previous blog discussed the use of standards to support regulation in Europe and in the USA. The Medical Devices Regulation (MDR) introduces a new concept alongside harmonized standards, called Common Specifications (CS). These are included in the In Vitro Diagnostic Medical Devices (IVD) Directive where they were called Common Technical Specifications and were for Annex II List A products. They are now renamed and have been incorporated in Article 9 of both the MDR and the In Vitro Diagnostics Regulation (IVDR).

The regulations give the EU Commission authority to prepare a CS in three situations - where: 1) no harmonized standards exist; 2) where relevant harmonized standards are considered insufficient; or, 3) there is a need to address public health concerns. A CS can address:

• 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).

The procedure for preparing a CS requires that the Commission initially seeks advice from the newly established Medical Device Coordinating Group (MDCG) made up of experts nominated by EU member states. The MDCG is set up under Article 103 of the MDR and Article 98 of the IVDR. The process for drafting a CS is not described but should include consulting relevant stakeholders and taking account of European and International standards. Adoption of a CS requires positive opinion by weighted majority vote in another newly-established committee, the Committee on Medical Devices, made up of representatives of member states. 

As with harmonized standards, devices that are in conformity with a CS are presumed to be in conformity with the requirements of the Regulation covered by that CS. However, the regulations go on to state explicitly that manufacturers have to comply with the CS unless they can justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent.  

Additionally, certain groups of products for which a manufacturer claims only an aesthetic or other non-medical purpose, but which are similar to medical devices in terms of functioning and risk profile, have been bought in under the MDR. These are referred to as devices without an intended medical purpose and are listed in Annex XVI of the MDR. Examples include contact lenses without a corrective function and dermal fillers. The Commission is specifically directed to adopt CS on application of risk management and clinical evaluation regarding safety of devices without an intended medical purpose. Manufacturers of these products have to comply with the relevant CS for those products. These CS are not to be used for conformity assessment of similar devices with a medical purpose.

Common Specifications may also be used in the area of reprocessing single-use devices within a health institute, the requirements will cover risk management, validation of procedures for the entire process, product release and performance testing, quality management system, reporting of incidents and traceability of reprocessed devices.

You need to be aware of this concept in the MDR and IVDR and watch out for development of CS for devices and IVDs as they could have a significant effect on how you will need to comply with the regulations.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.