The author reviews the essential requirements for medical device CE marking. Common mistakes to avoid, and the proposed EU regulations are also discussed.
Essential Requirements (ERs) are the requirements for safety and performance specified in Annex I of the three medical device directives. ERs are divided into Part I (i.e., – general requirements) and Part II (i.e., – requirements for design and construction). Evidence of conformity must be provided for all general requirements in Part 1 for all devices—regardless of risk classification, design or construction. The Design and construction requirements in Part 2 may be not applicable, depending upon your device.
When a Notified Body reviews your Technical File or Design Dossier for CE Marking, the auditor must verify that you have addressed each ER. This is typically demonstrated by providing an ER Checklist (ERC). You can find a template for an ERC on the International Medical Device Regulators Forum (IMDRF) website (http://bit.ly/IMDRFDoc) in Appendix A (see example in Figure 1 below) of the GHTF Guidance document explaining the use of a Summary Technical Document (STED) to demonstrate conformity with the principles of safety and performance (http://bit.ly/GHTFSTEDGuidance).
Figure 1: Example of an ERC
To demonstrate compliance with the ERs, you must provide the following information by filling in the four columns of the ERC:
- Applicability to your device,
- Method used to demonstrate conformity with the ER,
- Reference to the method(s) used, and
- Reference to the supporting controlled documents.
Subparts & Common Mistakes
Completing the ERC would be easy if there were only 13 ERs, but eight of the 13 ERs have multiple requirements. For example, ER 13.3 has 14 subparts (i.e., – 13.3a through 13.3n). Each subpart must be addressed when you complete the columns of the ERC table. If any of the parts in ER 7-13 are not applicable to your device, you need to provide a justification. For example, ER 11 and its subparts are not applicable to devices that do not emit radiation. This justification must be documented in the ERC for each subpart.
When you write your justification for non-applicability of an ER, you need to be careful to provide a justification for each part of the requirement. For example, there are three sub-parts to ER 7.5. Each part is a separate paragraph, but these are not identified by a letter, as is done in ER 13.3 and 13.6. Instead, each subpart is a separate paragraph. Within those paragraphs, there is further room for confusion. For example, the third paragraph states that if you use Phthalates in a product that is intended for women or children, then you must provide a justification for its use in the technical documentation, in the instructions for use, within information on the residual risks for these patient groups (i.e., –women and children) and, if applicable, on appropriate precautionary measures.
Proposed EU Regulations
The proposed EU Medical Device Regulations (MDR) are organized into Articles and Annexes–just like the current EU Directives, and the ERs will still be the first Annex of the MDR. However, there will be 19 ERs, instead of 13. The early reviews of the proposed regulations indicated that there were no significant changes, but I have learned the hard way that you should always go to the source and verify the information for yourself. The general organization of the Essential Requirements is still the same, but there are several significant changes that will require providing additional documentation in your Technical File or Design Dossier for CE Marking. Most companies will probably submit a revised ERC to address the new requirements, but you may want to read Medical Device Academy’s review of the new ERs (http://bit.ly/NewERCGap) and prepare accordingly.
Essential Principles Checklists
Health Canada has an Essential Principles checklist (EPC) that is similar to the European ERC, and Australia has a similar document (http://bit.ly/EPCTGA) with only a few minor differences, and the Global Harmonized Task Force (GHTF) created an earlier version in 2005 (http://bit.ly/EPSafetyPerf). Health Canada will typically accept your ERC developed for the European Medical Device Directive (MDD), but a gap analysis should be performed against the Australian Regulations.
Now that the ENVI vote has passed (http://bit.ly/ENVIVotepasses) I asked a new consultant working for me to create a template for the new Essential Requirements in the proposed regulations. You can download this FREE template at: http://bit.ly/NewERCTemplate. This new template also indicates the items that were recently modified (see the redlines).