Expected undesirable side-effects

Because they are expected and weighed in the benefit-risk assessment, they are not reported one by one as serious incidents. A significant increase in their frequency or severity has to be reported through MDR trend reporting.

Expected undesirable side-effects must be clearly documented in the product information and quantified in the manufacturer’s technical documentation. They must also be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the medical device during normal conditions of use (Section 8 of Annex I MDR).

MDCG 2023-3 Rev.2, Question 10