Article 8 of the MDR with regard to the Use of Harmonized Standards specifies that “Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.”
When applying the regulation, the questions that naturally arise are:
- which requirements of the regulation are being satisfied with any specific harmonized standard;
- whether harmonized standards are then obligatory to conform with the requirements of the Regulation;
- which harmonized standard(s) are expected to be applied; and
- which version of the standard is required at which moment in the device’s lifecycle.
Which requirements of the regulation are satisfied by Harmonized Standards?
Harmonized standards are applied to product design to demonstrate a presumption of conformity with the General Safety and Performance Requirements (GSPR’s) of Annex I. The adopted European Norm often has an appendix (Annex Z) which entails that compliance with the standard provides a means of conformity with the specified essential requirements of the concerned regulation (since we’re talking MDR Art 8, not Art 5 MDD). Essentially, it provides a “map” from the clauses of the standard to the sections of the applicable regulation (e.g. MDR) for which meet the requirements in the standard gives the presumption of conformity to those parts of the regulation, thereby giving the manufacturer guidance in the completion of the GSPR checklist. By applying the European standard, the manufacturer is effectively addressing the safety and/or performance requirement with a recognized and harmonized methodology as determined by the Commission, however, it warns that other requirements and other regulations may be applicable.
Is the application of a harmonized standard obligatory for conformance with Medical Device Regulations?
The Regulations do not specify that application of harmonized standards are compulsory for addressing the GSPR’s. The requirements are flexible enough to permit manufacturer’s the freedom to demonstrate safety and performance by other means, and therefore it is considered acceptable to apply other standards or methodologies to meet the GSPR’s other than the application of harmonized standards. However, the manufacturer carries the burden of proof to demonstrate that the applied standard or methodology is equivalent to or better than the safety and performance demonstrated by the harmonized standards. In the case of medical devices classified higher than class I, the Notified Body would expect to see a robust rationale for applying a different approach to conformity when a harmonized standard is identified and applicable to the device. While a gap analysis between the applied standard and the harmonized standard is often prepared and may suffice to adequately show equivalence of the requirements with respect to the device under review, this method may be limited to standards that are similar to the harmonized standard (e.g. an older version of the standard). A more robust analysis and rationale may be required for dissimilar standards or methods.
However, the MDR has evolved to take a stricter approach than the MDD by permitting the Notified Body the prerogative to “take into consideration available CS, guidance and best practice documents and harmonized standards, even if the manufacturer does not claim to be in compliance (Annex VII 4.5.1).” While the manufacturer may have compiled a robust analysis and rationale for the use of alternate standards or methodologies, this bottom-line statement gives the Notified Body the leverage to challenge the rationale when it considers the state-of-the-art as higher precedence.
Which harmonized standard(s) are expected to be applied?
There are hundreds of standards harmonized to the Medical Device Directive 93/42/EEC (not yet for the MDR). It is not expected (nor intended) that all harmonized standards are to be applied to each medical device. Many of the standards would not be considered relevant to the device under question. The relevancy to the device can be determined by the scope of the standard. When the scope of the standard is applicable to the device, and it doesn’t specifically exclude the device (as determined by the exclusions), then the standard may be applied to demonstrate a presumption of conformity. The manufacturer is not obligated to document whether the harmonized standard is applicable to the device or provide a rationale why the device is not applicable. However, Notified Bodies are qualifying the reviewers for their knowledge and experience with specific device categories. A qualified reviewer is expected to know which standards are applicable for a specific device category and would assess the technical documentation for conformity with the standard or justification for applying a different method and the rationale for determining an equivalent measure of safety and performance.
For example, a device may have been designed to include visual or audible alarms to indicate information to the user. IEC 60601-1-8 is a harmonized standard that applies to safety and performance of medical electrical equipment and provides specific requirements for alarm systems and alarm signals in medical electrical equipment and medical electrical systems. After review of the terminology, the standard is determined to be applicable when an alarm condition is present. If the alarm signal provided by the functionality of the device is intended only to provide information to the user, and no alarm condition has been identified by the manufacturer, it can be justified that the standard is not applicable. In this case, a rationale for the inapplicability of the standard would be expected and reviewed if the standard was not applied to the device.
With respect to the Medical Devices Regulation EU 2017/745, no standards have yet been harmonized as of the date of this article. The European Commission has published in June 2019 a Notification under Article 12 of Regulation EU No. 1025/2012 proposing a list of potential harmonized standards and their anticipated deadlines for adoption. According to this Notification, with the exception of a few key (horizontal) standards, a majority of existing and new standards are expected to be adopted into regulation by May 2024. Horizontal standards are applicable to every type of medical device whether active or passive, irrespective of application or duration, and regardless of risk classification. Quality management and risk management are horizontal standards as they are applied to every medical device. On the contrary, vertical standards are those that are specific to a type of medical device or feature/aspect of those devices. EN 60601 is a vertical standard as it only applies to active medical devices. The initial key horizontal standards are fundamental for establishing a quality management system, risk management procedures, good clinical practices, and utilization of symbols, and are expected to be adopted in May 2020 as of the date that the MDR transitions into enforcement.
As of May 2020 when the MDR transitions into full enforcement, only a select few standards are anticipated to be harmonized as of that date. So manufacturers will not be given the option to apply harmonized standards as a “presumption of conformity” to the general safety and performance requirements until several more years in the future. There is speculation that notified bodies may permit the manufacturers to justify using the currently harmonized standards under the MDD as the basis of a “presumption of conformity” assuming that any major gaps or differences between the regulations have been considered within the rationale.
Which version of the standard is required at which moment in the device’s lifecycle?
The Official Journal of the European Union documents the specific title and reference of the standard including the year of publication. In addition, it references superseded standards, or versions of the standard, that have been obsoleted; and it provides the date of cessation of presumption of conformity of the superseded standard. When an updated or newer version of a harmonized standard has been adopted as regulation, there is usually a transition period established for manufacturers to identify the changes and transition the new standard requirements into product design. The date of cessation of presumption of conformity reflects the date by which the requirements become regulatory, thereby superseding previously harmonized versions which become obsolete at that time.
As standards evolve, they are either amended or revised. When the general concepts of the standard are maintained, but there is a significant number of changes (whether corrections or clarifications) to be implemented, then an amendment to the standard will get published, and the amendment will be read in conjunction with the original version. When a proposed change or a trend analysis shows that the standard’s concept is failing to keep up with technology or changes in regulations, then a standard revision may be published, which effectively incorporates all previous amendments and current changes into a new and state-of-the-art version of the standard.
For example, EN 60601-1-8:2007/A11:2017 for general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems has transitioned to become regulatory in January 2020 after a 3 year transition. The 2007 revision of EN 60601-1-8 is the 2nd edition of this standard which became regulatory in June 2012. The A11 amendment is to be applied in conjunction with the harmonized standard (EN 60601-1-8:2007) and effectively supersedes the 2nd edition standard from being used without the amendment.
Medical devices placed in the EU market are obliged to maintain conformity with EU Regulations throughout the product lifetime, as well as for a specified number of years following the cessation of entry of product into the market. The technical documentation is expected to be a living document that is maintained to the “state-of-the-art” during this product lifetime. Consequently, manufacturers are expected to be aware of changes in the EU Regulation, identify the current “state-of-the-art”, and update the technical documentation accordingly for continued conformity with the Regulations. This may require periodic monitoring of the Official Journal for changes in harmonized standards.
In summary, while harmonized standards are published in the Official Journal of the European Union to recognize the current “state-of-the-art” and provide manufacturers with a means to presume conformity with the requirements, application of the harmonized standards are not obligatory. However, the manufacturer bears the burden of proof to satisfactorily demonstrate that an alternative standard or methodology provides an equivalent or better level of safety and performance as that provided by the harmonized standard. It is also the manufacturer’s responsibility to maintain the technical documentation to reflect the current “state-of-the-art” as new versions of harmonized standards transition into regulation.