Independent clinical evaluation of medical devices
Clinical evaluations of medical devices mean: The objective analysis and evaluation of clinical data on a specific medical device. The aim of the evaluation is to demonstrate the performance and safety of the medical device in use.
The evaluation is based on clinical data from the scientific literature or data from clinical trials.
The clinical evaluation is part of the conformity procedure for medical devices, which leads to the CE marking. The clinical evaluation is part of the technical documentation or medical device file. It is updated at regular intervals after the medical device has been placed on the market - taking into account the results of market observation and experience with the medical device.
OBJECTIVES, BASICS, CLINICAL EVALUATION REQUIREMENTS
Clinical evaluation objectives
The manufacturer of a medical device must demonstrate compliance with the basic requirements for the medical device as part of the approval process and after placing it on the market. In this context, the clinical evaluation helps to demonstrate the safety and effectiveness of the medical device, taking into account the applicable regulations. The following is determined:
- whether the clinical benefit is sufficient and decisive.
- whether there were unexpected or unacceptable side effects or whether new risks were identified.
- whether the information about the product, e.g. announced effects (product description or marketing brochure) are verifiable.
- whether and which activities as part of the PMCF (Post-Market Clinical Follow-Up) have to be planned and carried out
Basics of clinical evaluation
The clinical evaluation is based on scientifically based clinical data. If these are already available to a sufficient extent, the clinical evaluation can be carried out using literature or database searches (including reference products). However, there is a growing demand for data from clinical trials and clinical studies.
Various sources and databases are used to determine the clinical data, e.g .:
- Homepage of the responsible authorities, e.g. BfArM
- FDA databases, such as MAUDE and Medical Device Recall
- Results from clinical trial databases, e.g. ClinicalTrials.gov
- Feedback from application monitoring
- Press releases
Requirements through standards and regulations for clinical evaluations
Of the multitude of regulations, the following are particularly noteworthy:
- Medical Device Directive 93/42 (MDD) Annex X
- §19 Medical Devices Act MPG
- EU Regulation 2017/745 on medical devices (MDR)
- MEDDEV 2.7.1 rev. 4th
Further regulations apply to clinical trials - e.g .:
- Medical Devices Act (MPG) §§20ff
- DIN EN ISO 14155 Clinical investigation of medical for human subjects - Good clinical practice
- Medical Devices Clinical Testing Ordinance (MPKPV)
QIP GMBH - YOUR PARTNER FOR INDEPENDENT CLINICAL EVALUATIONS
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We are happy to answer your questions about clinical evaluation.
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When creating the independent clinical evaluations for your medical device according to MEDDEV 2.7 / 1 rev. 4 (06/2016) we can draw on the extensive experience of our employees in this area and related areas.
In addition to our doctoral team, actively practicing doctors with their specialist knowledge of medicine, medical technology and medical informatics are available exclusively for our clients as consultants.
- Experience of more than 30 years in scientific and clinical work
- Your clinical assessment will be written by experienced employees with appropriate qualifications (including a doctorate in the life sciences area).
- Based on our experience, we create your clinical assessment quickly, to a sufficient but not excessive extent, in a manner that conforms to standards.
- We take on all related services in a highly qualified manner - we look after you until the successful completion.