Mittelstandspresse
06.08.2026
TentaConsult connects regulatory expertise across the entire product life cycle
EUDAMED brings regulatory interrelationships to light
Berlin, 06.08.2026 (PresseBox) - Regulatory requirements must be taken into account well before market entry. Decisions are made as early as the development, quality management and scientific evaluation stages that shape subsequent evidence, product classifications and regulatory requirements. Those who only consider these interrelationships at the end of a process risk inconsistencies between documentation, the product concept and regulatory expectations.
TentaConsult Pharma & Med GmbH supports companies with medicinal products, medical devices, food supplements and cosmetics throughout the entire product life cycle. In doing so, the company combines regulatory, scientific and quality-related expertise. The focus is on how regulatory decisions and supporting evidence can be coherently integrated, even over the course of several years.
EUDAMED brings regulatory interrelationships to light
EUDAMED demonstrates just how relevant this cross-lifecycle perspective is in practice in the field of medical devices and in vitro diagnostic medical devices. Use of the first four modules has been mandatory since 28 May 2026. As a result, key regulatory information on economic operators, products, certificates and market surveillance is recorded in a more structured manner within a European system. This increases transparency regarding whether key product and stakeholder data is managed consistently. Intended use, classification, product identification and certificate details must be formally correct and correspond to the underlying supporting documentation.
If such details are not checked for consistency at an early stage, discrepancies often only come to light during enquiries from regulatory authorities, audits or change procedures. The effort required to rectify these issues is then usually significantly greater than if they had been clarified at an early stage. The example of EUDAMED thus illustrates a principle that extends beyond medical devices and in vitro diagnostic medical devices.
This logic also applies to other regulated product areas. Whether medicines, medical devices, food supplements or cosmetics: product information, scientific assessments, regulatory decisions and quality-related evidence must be consistently aligned within the respective legal framework. Changes should therefore always be assessed to determine what impact they will have on existing processes, documentation and assessments.
Market entry is not the end of the process
However, even after authorisation, conformity assessment or initial placing on the market, regulatory responsibility remains an ongoing process. Manufacturing processes change, suppliers change, new scientific findings emerge and legal requirements continue to evolve.
Admittedly, not every change requires a new regulatory procedure. However, the crucial factor is whether existing evidence, assessments and documentation remain robust under the changed conditions. Depending on the product, this may result in adjustments to authorisations, technical documentation, labelling, risk assessments or quality processes.
Particularly in the case of complex products and long product life cycles, regulatory decisions must be documented in a transparent manner and reviewed regularly. This is the only way to assess whether a product’s regulatory basis remains sufficiently sound even under changed conditions.
For TentaConsult, therefore, integrating the various specialist perspectives is at the heart of its consultancy practice. From the company’s perspective, it is not enough to consider individual regulatory requirements in isolation. Rather, it is crucial to identify interactions at an early stage and assess them from a cross-disciplinary perspective.
Ralf Sibbing, Managing Director of TentaConsult Pharma & Med GmbH, describes it as follows:
“A regulated product consists not only of individual documents, but of decisions that must be consistent with one another over the course of several years. If development, quality, authorisation and post-market surveillance are considered in isolation, contradictions often only become apparent when time and room for manoeuvre are already running out. Our aim is to highlight such interrelationships at an early stage.”
Assessing interrelationships across the entire life cycle
To identify such interrelationships at an early stage, TentaConsult supports companies with regulatory classification, strategy development and implementation throughout the entire product life cycle. This includes, amongst other things, authorisation and variation procedures, conformity assessments, technical documentation, clinical and scientific evaluations, and issues relating to product delineation.
The aim is to identify regulatory risks at an early stage, manage change processes in a transparent manner and, where possible, avoid the need for corrective action at a later stage. The consultancy combines regulatory expertise with quality management, GxP, audits, validation, data integrity, risk management, pharmacovigilance and market surveillance. This enables product changes, new risks and requirements arising from communication with regulatory authorities to be assessed on a cross-disciplinary basis and integrated into existing processes.
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TentaConsult Pharma & Med GmbH
+49 (251) 928715-60
Über Tentamus Group GmbH:
About TentaConsult Pharma & Med GmbH
TentaConsult Pharma & Med GmbH, with offices in Münster and Martinsried, advises life sciences companies on regulatory, quality-related and strategic issues. Its range of services covers regulatory affairs, quality management and pharmacovigilance, as well as support for medicinal products, medical devices, food supplements and cosmetics throughout their entire product lifecycle.
As part of the Tentamus Group, TentaConsult supports manufacturers from the early development phase through to post-market surveillance. The aim is to address regulatory requirements with technical precision, economic efficiency and a focus on practical implementation.
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TentaConsult connects regulatory expertise across the entire product life cycle
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