ACIG

ENGLISH 21 the first challenge presented by the evaluation: how can I verify the safety and performance requirements for my product, or its clinical benefits, by reference to the literature if I am launching an original, and perhaps even highly innovative product on the market? There will be little or no data in the literature about an original product, above all at the time of its first approval. It is here that the concept of ‘equivalent device’ comes into play. An ‘equivalent device’ is a product that possesses a high level of similarity to your own product. In this context, the MDR refers to ‘equivalence’. Annex XIV, section 3 specifies the three categories comprising this equivalence, i.e. technical, biological and clinical characteristics. According to this, an equivalent product can only be classified as such if no differences are found, or only clinically insignificant ones. The MDCG Guideline 2020–5 may also be consulted for more details on this. This guideline itemises the requirements, investigates specific points within the categories and, at the same time, contrasts the requirements of the MDR with those of MEDDEV 2.7/1 rev. 4, the guideline for clinical evaluations under the MDD. Criteria for equivalence: • Technical equivalence: Technical equivalence means that the product has the same or a similar design, is used under similar conditions, and that the physical and chemical properties correspond. In its use of the term ‘simi- lar’, therefore, the MDR provides a certain scope for freedom. Here it refers to comparable principles which, in the final analysis, add up to the same result. Here too, the rule is that the ‘equivalence’ should not influence the clinical intention. The MDR also goes one step further here by mentioning software algorithms. These too should have a similar way of functioning and method of development. • Biological equivalence: Here the MDR requires the manufacturer to check their medical device and potentially equivalent products to see whether the same substances come in contact with the same tissues, and whether these possess similar qualities with regards to degradation products and leachables. This must occur for a comparable, i.e. similar, time period. The difference between ‘similar’ and ‘same’ is also to be understood in exactly the same way in the directive. It is therefore important that two equivalent products are actually made of the same materials or use the same substan- ces to achieve their clinical effect. As for as the exposition goes, here again the MDR allows a certain free scope. It goes without saying that one should not stretch the term too far. • Clinical equivalence: This section is certainly the least ambiguous, since it refers directly to the indicated clinical condition and the purpose of the medical product. Obviously, in the case of an equivalent device, these must also be the same. Here the MDR is also quite strict, and gives no scope for discretion where the clinical condition is concerned. Here, only severity and