Independent performance assessments of in vitro diagnostics

A performance assessment of in vitro diagnostic medical devices is an assessment or analysis of data to check or determine the scientific validity, the analytical performance and, if applicable, the clinical performance of an in vitro diagnostic medical device.

The performance evaluation is intended to scientifically prove that the intended clinical benefit is achieved and that the in vitro diagnostic medical device is safe.

The performance evaluation report is part of the technical documentation. In the performance evaluation, the data on scientific validity, clinical performance and analytical performance are assessed and the clinical evidence derived from this is documented.

Throughout the entire life cycle of the in vitro diagnostic medical device, the performance evaluation and the associated documents are based on the data from the implementation of the plan for the post-market performance review PMPF) and post-marketing surveillance plan.

Independent performance assessments of in vitro diagnostics

OBJECTIVES OF THE IVDR PERFORMANCE EVALUATION

The aim of the performance assessment is to demonstrate clinical safety, performance and a positive benefit-risk ratio for the designated and intended use of the in vitro diagnostic medical devices.

Three subject areas determine the content of the performance evaluation (IVDR):

Scientific validity

Scientific validity describes the relationship between an analyte and a specific clinical or physiological condition.

Analytical performance

Die analytische Leistung eines Produkts beschreibt dessen Fähigkeit, einen bestimmten Analyten korrekt nachzuweisen oder zu messen.

Clinical performance

The analytical performance of a product describes its ability to correctly detect or measure a particular analyte.

Principles of performance evaluation

With the performance assessment, you as the manufacturer use suitable means to demonstrate that the IVD that is placed on the market fulfills the basic safety and performance requirements of the IVDR.

An independent performance evaluation (IVDR) is based on scientifically based clinical data and data from the diagnostic examination. If these are already available to a sufficient extent, the performance can be assessed using literature or database searches (including reference products). However, data from performance tests or performance studies is increasingly being requested.

Various sources and databases are used to determine the data, e.g .:

  • Homepage of the responsible authorities, e.g. BfArM, EUDAMED
  • FDA databases, such as MAUDE and Medical Device Recall
  • Results from databases on clinical trials, e.g. ClinicalTrials.gov
  • Feedback from application monitoring
  • Press releases

REQUIREMENTS THROUGH STANDARDS AND RULES FOR PERFORMANCE EVALUATIONS

Of the multitude of regulations, the following are particularly noteworthy:

  • 98/79 / EC IVDD Annex VIII
  • §19 Medical Devices Act MPG
  • EU regulation 2017/746 - IVDR
  • Preparation according to the Medical Implementation Act (MDG), MPEUAnpG
  • Based on methods of 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)

OUR EXPERIENCE - YOUR ADVANTAGE

We can draw on the extensive experience of our employees in this area and related areas when it comes to the approval of your medical devices, individual questions about this procedure or services related to it.

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 technical documentation is written by experienced employees with appropriate qualifications (including a doctorate in the life sciences area).
  • Based on our experience, we create your documents quickly, to a sufficient but not excessive extent, in a standard-compliant manner.
  • We take on all related services in a highly qualified manner - we look after you until the successful completion.

We are happy to answer your questions about independent performance evaluation.

Now ensure your access to local markets around the world and at all times. Reduce your costs by streamlining your work and administration. Gain greater security for your products, your documentation and your processes. Accelerate your time to market now. Your competent partner will be happy to assist you.

QiP GmbH - your partner

Our services / content of your independent performance evaluation:

For your in vitro diagnostic medical device we create an independent performance evaluation according to EU regulation 2017/746 IVDR with the following essential content:

  • Product description in detailed form and description of the diagnostic basics
  • Extensive scientific database - queries and literature searches in various sources
  • Search for reference products
  • Assessment and analysis of the equivalence of the reference products
  • Evaluation of the results of the research
  • Assessment of the information described in the literature / databases, including incidents and recalls
  • Analysis of the information available in-house (parts of the technical documentation) or the data obtained and derivation of recommendations for risk management
  • Weighing the risk / benefit ratio
  • Drawing up a PMPF plan in consultation with you

In principle, we can accompany you in all points of the procedure. We would be happy to advise you free of charge and without obligation on a possible service package for your specific product / project.

The first step is sometimes the easiest - but also the most important one: contact us


contact us