Use of Harmonised Standards
Although this guidance document does not include new information, it is especially helpful for medical device start-ups and manufacturers, which are at the beginning of their design phase. Once again, it answers the important question which many manufacturers have in mind; “Shall I comply with a harmonised standard? “
Paragraph 2.2 of MDCG 2021-5
…based on the principles of the “New Approach” and the “New Legislative Framework” policies, the use of standards (either harmonised European standards cited in the Official Journal of European Union or any other standard) in the medical devices sector is and remains voluntary…..
Of course, manufacturers shall not forget that compliance with a harmonised standard enables a high level of conformity to the essential requirements of medical device directives and general safety and performance requirements of the medical device regulations.
State of the Art Concept
Another useful section of MDCG 2021-5 is the paragraph 3.5, where the concept of “state of the art is explained. The paragraph makes clear distinction between terms “taking into account” and “compliance”. Manufacturers have to bear in mind that state of the art is a non-legally established definition.
This section is especially useful to understand what the medical device regulation means by the phrase ““take into account the generally acknowledged state of the art” for demonstration of compliance.
Apart from voluntary use of standards and state of the art concept, the guidance document includes information about the regulatory framework and international aspects of standardization.
We highly recommend that medical device manufacturers take the time to read this MDCG 2021-5 guidance. For sure it will contribute significantly to the design process and demonstration of compliance to the medical device regulations.