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This article reviews a controversial interpretation of the medical device CE Marking requirements with regard to risk management: specifically, reducing risks as far as possible without any room allowed for economic considerations.
ISO 14971 is the risk management standard for medical devices. The U.S. FDA and Health Canada have both recognized the 2007 version of this international standard, but the European Commission has identified seven deviations from the Essential Requirements of the European Medical Device Directives. The seven deviations are identified in Annex ZA of EN ISO 14971:2012. The list of seven deviations, and hyperlinks to a technical review of each deviation, are provided below.
1. Treatment of negligible risks
2. Discretionary power of manufacturers as to the acceptability of risks
3. Risk reduction “as far as possible” vs. “as low as reasonably practicable”
4. Discretion as to whether a risk-benefit analysis needs to take place
5. Discretion as to the risk control options/measures
6. Deviation as to the first risk control option
7. Information of the users influencing the residual risk
The first four deviations apply to all three directives, but the last three are not specifically identified as deviations from the Active Implantable Medical Devices Directive. Compliance with the European Directives is required for CE Marking of medical devices, and the directives have not changed. Therefore, some manufacturers will have procedures and risk management files that already comply, while others may have corrective actions to take. The most challenging corrective actions are likely to be specific to the third deviation.
Deviation No. 3
The third deviation states, “various Essential Requirements require risks to be reduced ‘as far as possible’ without there being any room for economic considerations.” However, the concept of “economic considerations” is not mentioned anywhere in the Essential Requirements (e.g., Annex I of the Directives). In fact, the only place in the directives where the words “economic considerations” are actually used is in the preamble to the directives. Although this is not part of the Articles or Annexes in the directives, this clearly indicates that eliminating all possible economic considerations was not the Commission’s original intent.
The Active Implantable Medical Devices (AIMD) Directive does not mention “economic considerations” anywhere, and the other two directives contradict the wording of the deviation in EN ISO 14971:2012. The Medical Devices Directive (MDD) states that risk reduction “must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety.” The In Vitro Medical Devices Directive (IVDD) states, “whereas the essential requirements, including requirements to minimise and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and technical and economic considerations compatible with a high level of protection of health and safety.”
Product Safety Standards
“As far as possible” is not the requirement for electrical medical equipment, because otherwise, devices that are safe in a single-fault condition would not be safe enough and the IEC 60601 series would not have been harmonized with the European directives. Other examples of product safety standards exist wherein the prescribed risk controls fall short of “as far as possible,” but these product safety standards represent the current “state of the art.”
ISO 22442-1, the standard defining the process for application of risk management to medical devices utilizing animal tissues, states that manufacturers shall comply with the relevant requirements of both ISO 22442-2 and ISO 22442-3. However, if there were no room for “economic considerations,” manufacturers would be forced to use only animal species that are BSE and TSE-free. Manufacturers would not be allowed to utilize collagen from BSE-free herds in New Zealand that were processed according to the ISO 22442 series of Standards. This is an extreme interpretation that is not consistent with the EU directives.
Position of EU Commission
The dispute over the issue of economical considerations was discussed with the EU Commission; however, the Commission rejected all arguments from manufacturers, the ISO committee and Notified Bodies. In Annex D8, the ISO 14971 Standard introduces the “As-low-as-reasonably-practicable approach.” (We refer to this as ALARP.) This approach is worded in such a way that it conflicts directly with the Essential Requirements of the directives. Instead of limiting the third deviation to the content of Annex D8, however, the EU Commission has redefined the Essential Requirements to exclude any room for economic considerations. Competent Authorities are making specific interpretations of how the respective clauses of EN ISO 14971:2012 shall be enforced during audits, but there is no MEDDEV providing additional guidance on the application of the clauses.
How to Comply Deviation No. 3
In order to comply with the third deviation, manufacturers need to review procedures and risk management files carefully for two things. First, there should be no mention of “ALARP.” It’s not enough to just change the wording from “ALARP” to “Moderate.” Manufacturers should make sure that documentation meets the intent. The decision to not implement a risk control should be because the risk control will not further reduce risk.
Second, risk management documentation needs to define “state of the art” with regard to risk controls. “State of the art” needs to be based upon a thorough postmarket surveillance and clinical evaluation that includes competitor products. Any residual risks need to be clearly identified in risk documentation, but each residual risk should be identified in the clinical evaluation, as well. In order to demonstrate that implementing a specific risk control is unnecessary, manufacturers need to provide scientific arguments and/or clinical data to demonstrate that the additional risk control will not further reduce risks. Arguments of cost will not provide sufficient justification for failure to implement a risk control.
Robert Packard is a regulatory consultant with 20 years of experience in the medical device, pharmaceutical and biotechnology industries. Robert served in senior management at several medical device companies, including President and CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing and maintaining ISO 13485 and ISO 14971 certification. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE Marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached at rob@13485cert.com.
Medical Device Academy
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Erik Vollebregt is a life sciences and intellectual property lawyer based in Amsterdam. He is founding partner of the boutique life sciences law firm Axon Lawyers, which specializes in EU legal and regulatory issues relating to medical technology. His particular focus is the European regulatory requirements for medical devices, and he is author of a blog on the same topic: medicaldeviceslegal.com.
