New Regulations on Notified Bodies and Conformity Assessment of High- Risk Medical Devices in Europe: Impact on Clinical Investigation from an Industry Perspective : Table 2

Table 2: Extract of regulatory changes to Notified Bodies and conformity assessment processes.

Regulatory change	Existing regulation	New regulation
Supervision of NBs	No standard requirements	Increased oversight and quality assurance by competent authorities and MDCG/ACMD. Notified Bodies will be monitored
Scrutiny Procedure	No conformity assessment by other regulatory authorities, only performed by Notified Bodies	MDCG and ACMD will have the ability to request preliminary conformity assessment. Manufacturers will be randomized to this scrutiny process. This means only a few devices will go through the extended conformity assessment process.
Competence	No standard requirements of competence	NBs expected to have permanent competent personnel and technical and medical expertise in-house. Competence must be documented.
Conformity assessment process	Heterogeneity in Notified Bodies’ work. Variations in the interpretation of regulations. Some more relaxed to regulatory requirements when providing CE Marking.Patients are subject to different safety levels.	Standardized processes through regulation instead of directives. Stronger requirements for clinical evidence.
Audit manufacturers	Only announced inspections, approximately every third year, as well as unannounced audits.	Subject to unannounced inspections. Inspections should be annual. Unannounced audits will bring extra costs to the manufacturer.
Clinical evidence	Evidence requirements vague. Based on ethical and methodological principles. Equivalence data used as evidence, based on previous studies and comparative literature. Safety and performance of device.	Standardized evidence requirements. Manufacturer must draw up a report on safety and performance aspects. Each new device preferably requires clinical investigation based on own data. Use of equivalence data requires stricter evidence and criteria. Justify not using randomized controlled trials Performance now includes efficacy and benefit to patient
Transparency	Non-transparency. No documents are available to the public, including data sent by manufacturers for assessment, which NB that assessed the pieces of clinical evidence and what the NB made their decision upon. Enable companies to shop around for the less strict NB and/or the cheapest, as well as to cooperate in an unethical manner with NBs.	One will have access to data submitted for approval, the rationale for a NB’s decision and which NB that have assessed a particular medical device. Clinical investigation results must be summarized and in Eudamed within a year.