After almost 25 years, the law on medical devices has changed. The “old” EU Directives (Medical Device Directive (MDD) 93/42 / EEC and Active Implantable Medical Devices Directive (AIMDD) 90/385 / EEC) were replaced by the Medical Device Regulation (MDR) 2017/475. European Union law considering medical devices has changed from...
What is considered burdensome or invasive? Where the investigation would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the Sponsor shall notify the Member States concerned at least 30 days prior to...
Which regulatory pathway should a Sponsor follow to conduct a clinical investigation in the pilot stage (i.e. first in human, early feasibility) in accordance with the Regulation (EU) 2017/745 (MDR)? The MDR describes different types of clinical investigations that follow different regulatory pathways. The choice of the appropriate regulatory pathway...
What are the general differences and improvements related to clinical investigations under the new Regulation (EU) 2017/745 (MDR) as compared to the Directives 93/42/EEC and 90/385/EEC? Regulation (EU) 2017/745 (MDR) will progressively replace both Directives (93/42/EEC and 90/385/EEC) and their transpositions in national law. The first difference is regarding the...