An overview of our services

Many start-ups, software teams and new product initiatives are dealing with the MDR, IVDR, standards and regulatory requirements for the first time. It is often unclear at first whether a product should be classified as a medical device or an in vitro diagnostic, which risk class it falls into and what requirements this entails.

Possible questions:

• Is our product a medical device or an in vitro diagnostic?
• Does the MDR, the IVDR or another regulation apply?
• Which risk class is our product likely to be assigned to?
• Which regulatory requirements do we need to take into account from the outset?
• What is a realistic path to CE marking and market entry?

Suitable service: Market Access Compass

Your benefits: We’ll quickly assess your regulatory status, identify key risks and work with you to develop a sound strategy for the next steps.

Innovative medical devices, in vitro diagnostic medical devices, software solutions and data-driven technologies often emerge at the intersection of medicine, digitalisation, AI, the data economy and clinical practice. As a result, the regulatory path is determined not only by the MDR or IVDR, but also by related legal frameworks, market requirements and strategic product decisions.

Possible questions:

• What regulatory requirements apply to our planned product or digital health solution?
• How do technology, medical need and the healthcare context influence the regulatory pathway?
• What role do related legal frameworks such as SGB V, the AI Act, the EHDS, and data protection and cybersecurity requirements play?
• What intended use, qualification and classification are viable for our project?
• What are the next sensible steps for product development, regulatory implementation and market access?

Suitable service: Market Access Compass

Your benefits: We consolidate regulatory, technical and legal requirements into a viable overall strategy and provide guidance for the next decisions.

For realistic planning of CE marking, key questions must be clarified at an early stage: What is the specific intended use? What intended purpose is viable? Is it a medical device or an IVD? Which risk class applies? What evidence, documents and processes are required? Does a Notified Body need to be involved?

VDE Health supports you in answering these questions in a structured manner and drawing up a concrete roadmap for development, conformity assessment and CE marking.

Possible questions:

• What requirements arise from the intended purpose, qualification and classification?
• What evidence, documents and processes are required for CE marking?
• What regulatory action is required based on the current status of the project?
• What assumptions regarding time, effort and resources are realistic?
• In what order should the necessary steps be implemented?

Suitable service: CE Roadmap

Your benefits: You will receive a concrete roadmap setting out the necessary measures, realistic estimates of time and effort, and clear next steps towards CE marking.

Before an audit, conformity assessment, certification or approval, it is crucial that the product, software, technical documentation and processes are thoroughly prepared. Identifying the need for action at an early stage helps to avoid delays, rework and complaints.

Possible questions:

• What discrepancies and outstanding requirements remain?
• Are the documentation and processes sufficiently prepared for the procedure?
• What risks could prove critical during the formal procedure?
• Do our documents meet the expectations of Notified Bodies, testing laboratories and auditors?
• Based on experience, which points are likely to lead to queries during the audit or review?

Suitable service: Gap Analysis

Your benefits: We assess your project against the relevant standards and requirements, evaluate deviations and risks according to their relevance, and identify the next necessary steps.

Sometimes what is required is not a comprehensive analysis, but an independent assessment of a specific issue. This could be a question of interpretation, documentation, classification or compliance.

Possible questions:

• Is our intended use formulated in a sound manner?
• Is the classification of our product plausible?
• Is the intended evidence sufficient?
• How should a specific requirement of the MDR, IVDR or a standard be interpreted?
• Can our internal decision be justified on regulatory grounds?

Suitable service: Second Opinion

Your benefit: You receive an independent and well-founded assessment, giving you greater certainty for your future decisions.
 

Regulatory requirements must be translated into appropriate processes, robust evidence and verifiable documentation. This applies to the entire product life cycle: from quality management and technical documentation, through conformity assessment and registration, to post-market surveillance.

VDE Health supports you in the practical implementation of regulatory requirements. We assist you in establishing and further developing regulatory processes, in preparing and reviewing the necessary documentation, and in preparing for audits, assessment procedures and dealings with regulatory authorities. Even after the product has been placed on the market, we support you in fulfilling monitoring and reporting obligations, assessing product changes from a regulatory perspective, and keeping processes and documentation up to date.

Possible questions:

• What processes, documents and evidence do we need for our product, the intended procedure and our target markets?
• How do we ensure that our quality management, technical documentation and regulatory processes are suitable for inspection and audit?
• What requirements arise from CE marking, registration and placing on the market?
• How do we fulfil our obligations regarding market surveillance, vigilance and ongoing evaluation?
• How do we adapt processes and documentation to product changes, new regulatory requirements or additional markets?
• What operational steps are required to reliably implement regulatory requirements throughout the entire product lifecycle?

Relevant service: Regulatory Support

Your benefits: We support you throughout the entire product life cycle in the practical implementation of regulatory requirements, from development and conformity assessment through to market surveillance and post-market development. In doing so, we assist you in establishing and maintaining suitable processes, robust evidence and verifiable documentation.

Regulatory requirements do not only concern Regulatory Affairs or Quality Management. Development, Product Management, Software, Clinical Evaluation and Senior Management also need a shared understanding of the relevant requirements.

Possible questions:

• What regulatory knowledge do our teams need for their respective tasks?
• How do we translate requirements from the MDR, IVDR, standards and guidelines into our day-to-day development, quality and documentation work?
• What roles, responsibilities and interfaces do our teams need to be aware of?
• How do we establish a shared understanding of topics such as intended purpose, classification, technical documentation, clinical evaluation, software, cybersecurity and post-market obligations?
• What training content and formats are best suited to our product, our maturity level and the tasks of our teams?

Suitable service: In-house training

Your benefits: We empower your technical, quality, development and regulatory teams to implement regulatory requirements.