Compliant. Structured. Realistically planned.
MDR/IVDR & CE Marking
The path to European market access is complex and time-critical. We support manufacturers of medical devices and in vitro diagnostic devices in a structured and efficient manner throughout the entire process – from regulatory strategy to CE Marking according to MDR or IVDR.
A clear roadmap is what matters.
Whether a new product, MDR or IVDR transition of an existing product, or Recertification– regulatory requirements, time, and effort must be realistically assessed. We provide guidance, prioritize the next steps, and efficiently support you throughout your conformity assessmentprocedure.
What does your path to CE Marking look like?
Kostenfreies ErstgesprächOur services in the area of market access & CE Marking
Strategy & orientation
- You know the regulatory pathway for your product – with a clear MDR or IVDR strategy and approval roadmap
- You know exactly where you stand today – through a structured GAP analysis for CE readiness
- Your product classification according to MDR or IVDR is clarified and documented
- You know whether you are placing a medical device, combination product, or accessory on the market
- You enter approval projects with realistic time and cost planning
Implementation & support
- Your conformity assessment procedure is carried out in a structured, efficient, and timely manner
- Submissions and queries from notified bodies regarding technical documentation are answered in a technically accurate and pragmatic manner
- Reviews by notified bodies proceed without surprises
- Surveillance audits and recertification audits are prepared
- EUDAMED registration is complete and correct
- Your team is qualified and confident in handling regulatory requirements
- Technische Dokumentation ist ein zentraler Bestandteil jedes Konformitätsbewertungsverfahrens. Mehr zu unserem Leistungsbereich
→ Technische Dokumentation
Special requirements for specific medical devices
- Consultation procedures according to MDR Article 54 for high-risk products and products containing medicinal substances are professionally supported
- Consultations according to MDR Annex IX, Section 5 for Substance-based medical devices, as well as products containing materials of animal or human origin, are efficiently implemented
Clarity begins with the first step.
Whether initial orientation or complete project support – we provide the regulatory clarity you need for market access.
Besprechen Sie mit uns erste FragenWhen manufacturers come to us
New product
You need a clear and pragmatic roadmap to CE Marking according to MDR or IVDR.
Existing product (Legacy Device)
The MDR or IVDR transition must be approached in a structured and efficient manner.
Initial orientation
You are clarifying specific regulatory questions or preparing for a meeting with the notified body.
Our services
Our customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors
Frequently Asked Questions about CE Marking according to MDR or IVDR
Clear and consistent technical documentation creates confidence in the approval process and facilitates collaboration with notified bodies. Structured documentation helps map requirements traceably and avoid queries or delays in the review process.
This depends heavily on the product class, the initial state of technical documentation and quality management system, the need for a clinical investigation or external test laboratories, and the capacity of the notified body. As a rough guide: simpler class I products can be certified within a few months – more complex class IIb or III products often require one to two years. A realistic roadmap from the start is critical. This is exactly where we support you.
Ja. Produkte, die unter der MDD oder IVDD zertifiziert waren, müssen die Anforderungen der MDR bzw. der IVDR erfüllen – auch wenn sie seit Jahren erfolgreich auf dem Markt sind. Die gute Nachricht: Nicht immer muss alles neu aufgebaut werden. Wir analysieren Ihren Ausgangszustand und zeigen Ihnen, welche Anpassungen konkret erforderlich sind.
MDR-Konformität setzt ein funktionierendes QM-System voraus. Wenn Ihres noch nicht auf Stand ist: → QM & Auditbegleitung
For medical devices of classes IIa, IIb, and III, as well as certain class I devices
Notified bodies review whether technical documentation, quality management system, and clinical evaluation or performance evaluation are complete, consistent, and comprehensible. Notified bodies are not looking for perfect documentation – they are looking for documentation they can understand. This is exactly what we prepare you for.
There is no one-size-fits-all answer here – costs depend on product classification, complexity, and initial status. What we can offer you: a realistic evaluation based on your specific situation. Contact us – the first consultation is free of charge.
The MDR (Regulation (EU) 2017/745) governs medical devices; the IVDR (Regulation (EU) 2017/746) governs in vitro diagnostic devices. Both regulations place high demands on technical documentation, quality management system, and conformity assessment – but differ in product classification, clinical evidence requirements, and implementation timelines. We will clarify which regulation applies to your product and what that means in concrete terms during an initial consultation.
You don’t have to navigate the path to CE marking on your own.
Whether you’re at the start or in the middle of the process – we’ll assess where you stand and what needs to be done next. So that complexity is transformed into a clear next step.