Since the EU MDR (EU 2017/745) became fully applicable, manufacturers have faced significantly higher requirements for both existing and new products. In a 2022 MedTech Europe survey, 54% of respondents said they did not intend to transition parts of their existing portfolios to the MDR. For manufacturers, this means that without the required conformity assessment and CE marking, a standard medical device generally cannot be placed on the EU market. For marketers, it means regulation is part of the strategy.
What the MDR requires: short and practical
The MDR and, for in vitro diagnostics, the IVDR replaced the previous European MDD/AIMDD and IVDD frameworks. They set comprehensive requirements for clinical evidence, post-market surveillance, technical documentation, traceability, and UDI. For the market, this means greater regulatory effort and more extensive evidence requirements throughout the product lifecycle.
Low risk
Many Class I devices can be placed on the market without the involvement of a notified body. However, sterile Class I devices, devices with a measuring function, and reusable surgical instruments are subject to specific requirements and limited notified body involvement.
Medium to higher risk
Depending on their intended purpose and classification rule, these classes include various active, invasive, and implantable devices. A notified body is required, along with clinical evaluation and the appropriate technical documentation.
High risk
This class includes many implants and other high-risk devices. The strictest conformity assessment and clinical evidence requirements apply. PMCF can be an important part of the ongoing clinical evaluation after market launch.
The MDR as a commercial lever, not just an obligation
Identify gaps in the market
When competitors decide not to transition products to the MDR or remove them from their portfolios for economic reasons, gaps can emerge in the market. For manufacturers with an available alternative, this can create a commercial opportunity.
Trust as a differentiator
Valid CE marking is first and foremost a regulatory requirement for placing a medical device on the EU market, not a quality seal. In sales, however, clearly documented MDR compliance can still matter, particularly when customers evaluate continuity of supply, regulatory status, and long-term product availability.
Put clinical data to work
Post-market clinical follow-up can generate new clinical data after market launch and continuously update the clinical evaluation. Findings can also be relevant to scientific publications, product improvements, and, where supported by the evidence, communication about the product's clinical characteristics.
Use UDI for traceability
Unique Device Identification is designed to uniquely identify medical devices and improve traceability. For manufacturers, a well-integrated UDI system can create a structured link between product identity, regulatory data, and internal processes, but it doesn't replace a CRM or automatically provide customer data on product use or location.
The certification process: a realistic timeline
Confirm the classification
Clarify the risk class, intended purpose, and applicable regulatory requirements. The effort involved depends heavily on whether you're dealing with a new device, an existing device, or a change to an existing device.
Build the technical documentation
Compile the product description and specifications, design and manufacturing information, risk management, verification and validation data, and other evidence required under the MDR. The scope and timeline depend heavily on the device, risk class, and available evidence.
Clinical evaluation
Identify and evaluate available clinical data, generate new clinical data where necessary, and prepare or update the Clinical Evaluation Report. The required scope depends on the device, intended purpose, risk profile, and available evidence.
Conformity assessment by the notified body
A notified body is required for Class IIa, IIb, and III devices and, to a limited extent, for sterile Class I devices, Class I devices with a measuring function, and reusable surgical instruments. In an EU survey, 13–18 months was the most frequently reported timeframe from signed contract to certificate for QMS and product. Preparation by the manufacturer before that point is not included.
CE marking & PMS setup
Following successful conformity assessment, the required steps for CE marking and market launch can be completed. Post-market surveillance, vigilance, and, where applicable, PMCF then continue throughout the product lifecycle. Since May 28, 2026, the first four EUDAMED modules have been mandatory, including Actor Registration, UDI/Device Registration, and Notified Bodies & Certificates.
Letting marketing and regulatory work in separate silos. The intended purpose and the product characteristics supported by the regulatory evidence set the boundaries for what can be claimed about a medical device. Developing marketing claims without considering their regulatory and clinical basis creates a risk of inconsistencies between communications, clinical evidence, and technical documentation.
What good MDR management means for marketing
- Intended purpose ≠ unrestricted marketing promise: Claims about what a product does and what it is used for need to be consistent with its intended purpose and the available evidence.
- Set up claims management: Clinical claims such as “reduces infection risk by X%” need an adequate evidence base. That evidence can come from different clinical data sources and is continuously updated through clinical evaluation and, where applicable, PMCF.
- Communicate CE status clearly: CE marking documents regulatory conformity, but it isn't a quality seal. For procurement and other stakeholders in the buying center, regulatory status, certificate validity, and long-term product availability can still be important information.
- Tie launches to the certification calendar: If you're planning a launch around a medical conference, make sure the regulatory requirements for the planned marketing activities are met in time. The marketing calendar should follow the certification plan, not the other way around.
“The MDR isn't an obstacle on the way to market. It's the ticket. Companies that understand this build regulatory into the launch process from the start instead of treating it as a brake.”
Regulatory compliance gives you market access, but it doesn't give you a market strategy. Strategy emerges when you understand which opportunities changes in competitors' portfolios can create, what data the clinical and post-market processes provide, and how regulatory status and evidence matter across the buying center.
Sources: MedTech Europe (2022), Survey Report: Analysing the Availability of Medical Devices in 2022 in Connection to the MDR Implementation · European Commission/GÖG (2023–2025), Study Supporting the Monitoring of the Availability of Medical Devices on the EU Market · BVMed (2023), Herbstumfrage 2023 · Regulation (EU) 2017/745 (MDR) · European Commission (2026), EUDAMED.
Published June 2026