The starting point for choosing the standards to apply to a product is the analysis of the OJEU, the Official Journal of the European Union.
Under Directive 93/42/EEC, the Journal had reached a good level of completeness, providing an excellent starting point for researching and selecting standards.
With the advent of the MDR, this completeness has vanished, and standards bodies must work to develop regulatory updates that can provide presumption of conformity to specific general safety and performance requirements.
At this stage, the two main actors are the European Commission and the standardization bodies. The former has the role of urging the latter to implement the above, in order to harmonize the standards with Regulation 2017/745 (MDR).
The Commission’s activity to date has materialized through the following documents: Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 (October 29, 2020) and the Standardisation mandate 575 (March 12, 2021).
What makes these two requests unique is that they concern the harmonization of all standards by 2024. This will result in a significant lack of harmonized standards for the coming years.
To date, the standards harmonized with the Regulation and published in the Journal can literally be counted on the fingers of one hand. Specifically: one on irritation testing, three on sterilization, and the last one related to sterilizers.
Research and Selection of Standards to Apply
Given the current situation, manufacturers are once again in the position of creating their own rules for selecting standards, hoping that they will be shared by notified bodies and competent authorities.
Starting from the assumption that it is not possible to apply the correct selection process, let’s see how to approach the topic by defining specific conditions:
- The product is intended for the European market, so standards must be sought through the databases of European standardization bodies: ETSI; CENELEC; CEN.
- Many general safety and performance requirements of the MDR are totally overlapping with the essential requirements of 93/42/EEC. Standards covering these requirements – each harmonized standard has a table that relates its points to the covered requirements – can be used to give presumption of conformity to the Regulation as well.
- The two Commission documents mentioned earlier identify the standards to be harmonized and their revisions; it is presumable that a standard, when harmonized, will be mostly identical to the cited version. For example, for the 60601-1 standard, the European Commission urges the harmonization (by 2024) of the version: 60601-1:2006 + A1:2013 + AC2014 + A12:2014 + A2:2020.
- If the device was already certified under 93/42/EEC – thus developed in compliance with the standards harmonized to that Directive – before repeating the tests, it is essential to discuss this with the notified body. It’s worth remembering that products that have been on the market for years do not suddenly become unsafe or ineffective due to the entry into force of the new Regulation. The notified body is required to technically justify the reason for any non-acceptance of already available test reports.
- The two key words in this period will be: rationale and justification. As repeatedly stated, since it is not possible to apply the right process for selecting standards, it is necessary to create rationales to demonstrate the adequacy of the chosen standards. The previous point is certainly a coherent starting point.
New Standards, to be Harmonized in the Future
The European Commission’s harmonization requests also concern standards that have never been harmonized before. A list of the most notable ones:
- 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use
Applicable for some time to equipment such as: thermo-disinfectors, instrument washers, and blood bag irradiators, but with some difficulties in convincing the body that, for such products, although not harmonized, it is clearly more coherent than 60601-1. - EN 82304-1: Health Software – Part 1: General requirements for product safety
Dedicated to stand-alone software, it introduces safety features not currently present in the standard dealing with processes related to the SW life cycle: EN 62304. - EN ISO 10993-23: Biological evaluation of medical devices – Part 23: Tests for irritation
It should lay the groundwork for conducting irritation tests no longer in vivo, but in vitro. - EN ISO 17664-1: Information to be provided by the manufacturer for the processing of resterilizable medical devices
The most attentive manufacturers were already applying it, particularly for reusable surgical instruments; it establishes the minimum information to be included in user manuals to ensure correct reprocessing. - EN ISO 17664-2: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Medical devices not intended for direct patient contact
It establishes the information that the manufacturer must indicate in the manual to ensure a correct process for restoring cleanliness conditions for products that are not in direct contact with the patient. - EN ISO 20417: Medical devices – Information to be provided by the manufacturer
It should complete what is already present in EN 1041, which deals with the information that the manufacturer must include in the instructions for use, extending the reference to other accompanying documents as well. - EN IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle
EN 80001-1:2011: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management
They deal with aspects concerning cybersecurity, a completely innovative topic in the field of active medical device regulation, which will require particular attention.
These are among the most interesting, but depending on the area of interest, it’s possible to find others that will sooner or later be harmonized with the MDR.
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