Scrutiny procedure
The Scrutiny procedure (also: consultation procedure , English scrutiny - German precise examination ) was introduced by the European Medical Device Regulation (MDR). It stipulates that Notified Bodies involve an expert committee in the conformity assessment.
Conformity assessment
As part of the conformity assessment, manufacturers of medical devices determine the conformity of their products with the basic requirements of the European directives. To do this, they have to go through a conformity assessment procedure. Medical devices must meet the legal requirements. The most important of these legal requirements are the medical-technical performance of medical devices, as advertised by the manufacturer in the product labeling including advertising as a medical indication , an acceptable risk-benefit ratio, security from unacceptable risks, usability and compliance with software -Life cycle processes. The corresponding verification procedure is called clinical evaluation . Only the evidence of product safety and performance, certified externally by notified bodies (depending on the product class), entitles manufacturers of medical devices to affix the CE mark .
background
The expert reviewers at the notified bodies still saw the medical device directives as the only experts that had to be included. The European Commission no longer wants to rely solely on this. Obviously, it does not have sufficient confidence that the notified bodies have these experts for particularly critical and innovative products. In order to assess whether the manufacturer actually succeeds in providing this proof, experts are required. The Scrutiny procedure provides for the consultation of experts for specific products who control the clinical evaluation . The consultation procedure can be dispensed with if the products have already been placed on the market in a similar form and changes do not affect the benefit-risk ratio. The manufacturer must prove the latter.
Affected Products
Medical devices are divided into four classes I, IIa, IIb and III. According to Article 54 of the MDR, the consultation procedure only applies to the following products:
- Class III implantable products. This includes, for example
- Class IIb active products designed to deliver and / or remove a drug from the body, such as
Procedure
The manufacturer of a medical device submits his documents to the notified body . This checks the documents and gives a report on the evaluation of the clinical evaluation (clinical evaluation assessment report, CEAR) from. This report is submitted to the Commission, which (it to a panel of experts english Expert Panel ) forwards. The panel of experts decides whether to produce a scientific assessment report (CAR). If it does not create it, the notified body may continue the conformity assessment, otherwise the expert panel will prepare the report within 60 days.
literature
- Herbert Horne: I know MDR - Medical Device Regulation: German version . BoD - Books on Demand, November 21, 2018, ISBN 978-3-7528-5448-0 , pp. 13-14.
Individual evidence
- ↑ At a glance: placing medical devices on the market , BfArM. Retrieved March 14, 2019.
- ^ Text of the MDR , square. Retrieved March 15, 2019.
- ↑ Medical devices - classification , BVMed. Retrieved March 14, 2019.
- ↑ EU Medical Device Regulation: “A good compromise for more patient safety” , Device Med, June 13, 2016. accessed on March 14, 2019.
