Regulations (EU) 2017/745 (“MDR”) and council directive 93/42/EEC (“MDD”) as well as (EU) 2017/746 (“IVD”)

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL is a 175 pages regulation ((in Swedish: “en lag”; in Danish “en lov”) governing medical devices within the European market.

INSAKATO fully comprehend the requirements and expectations of this regulation, but also acknowledge the below areas are beyond our competences:

·         Type approval

·         Labelling

·         Clinical evaluation and post-market clinical follow-up

·         Clinical investigations

INSAKATO hence concentrate on the matter of MDR based on the first principles of physics, and is able to support you to navigate in this environment.

INSAKATO also understand the 60 pages COUNCIL DIRECTIVE 93/42/EEC (MDD)

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL a 157 pages regulation ((in Swedish: “en lag”; in Danish “en lov”) governing in vitro diagnostics within the European market.

IVD follows the identical principles of MDR.

The main difference to MDR is the often interaction with biological matter, such as body fluids (sweat, blood) or tissues.