What happened to the Essential Requirements?

Understanding the General Safety and Performance requirements in the new Regulations for medical devices is critical in planning your transition

Compliance with the ‘General Safety and Performance Requirements (SPRs)’ is a cornerstone in establishing conformity with the recently published Medical Device Regulation (MDR). The SPRs are detailed in Annex I of the MDR. The SPRs have replaced the Essential Requirements (ERs) found in Annex I of each of the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).

BSI have recently published a white paper comparing the ERs in the MDD and AIMDD to the SPRs in the new MDR.

There are 23 SPRs in the MDR, whereas there are 13 ERs in the MDD and 16 in the AIMDD. The scope and topics are consistent overall with the ERs of the Directives. However, there are a few notable exceptions.

For example, clinical evaluation and consultation on substances considered as medicinal products when placed on the market separately, have moved from the Annexes in the Directives into the articles in the body of the Regulations. New requirements address devices without a medical purpose and devices used by lay persons. Increased emphasis and more explicit SPRs have been included in some areas, which in many cases align with harmonized standards and existing guidance. Importantly, any new SPRs that were derived from voluntary consensus standards or guidance documents will now become European law under the Regulation. The SPRs that might have the greatest effect on manufacturers include requirements related to:

• medicinal substances and substances absorbed or locally dispersed;
• materials of biological origin;
• substances of concern, i.e. substances listed as being carcinogenic, mutagenic or endocrine disrupting;
• labelling;
• cybersecurity.

Understanding the SPRs will be an important aspect of manufacturers’ transition plans from the Directives to the MDR. Many manufacturers have ‘Essential Requirements Checklists’ embedded in their new product development processes. As we enter the transition period, it is important to consider the priority assigned to updating any such checklists to the SPRs. An SPR checklist could then be used for new projects so that new devices are compliant with the SPRs in the MDR when they come out of the new product pipeline. For development projects that are already in progress, the revised SPR checklist could be used for a gap assessment and considered together with the launch plan for the device to decide on the strategy to transition to the MDR. The SPR checklist could also be an important tool in reviewing your existing device portfolio in assessing the effort needed to transition current devices to the applicable regulation.

There are a number of resources available to help with transition planning, including MHRA’s Introductory Guide to new medical device regulations, MedTech Europe’s flowcharts of the regulations andBSI’s transition documents, free white papers and Compliance Navigator.

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.