PRO-LIANCE GLOBAL SOLUTIONS GmbH

MDR, Annex XIV, list of clinical evaluation activities The current wording does not reflect the actual logic of the clinical evaluation process and may therefore create confusion and inconsistent interpretation. First, the listed items are presented as a linear sequence, although in practice the clinical evaluation is not carried out in that order.

MDR, Annex XIV, last bullet in bullet list The current wording, and a PMCF, lacks clarity and may give rise to interpretative uncertainty. The use of the indefinite article suggests that the provision refers to one specific PMCF activity or measure, but the text does not identify which activity is intended.

MDR, Annex XIV, bullet list New bullet point on benefit-risk issues is not clear and easy to understand because "benefit-risk issues" are undefined. Proposal to improve the sentence to make it easier to understand: An indication of how component-specific benefit-risk considerations, including those arising from the use of pharmaceutical substances, non-viable substances of human origin, or non-viable animal tissues…

MDR, Annex XIV bullet list. Improve wording of "indicative list" to avoid confusion. The current wording is one of the sources of misunderstandings and most often deficiencies, creating a chicken-egg loop for manufacturers, leading to the CEPs that require the assessment of state of the art before the plan is done.