LIFE SCIENCES LAW - Ralph Schäfer – Lawyer - Your expert for legal issues in the life sciences sector
Lawyer for market entry for medical devices in Germany: Consulting and project management Starnberg
Services in MedTech and Health Care
Anyone wishing to market a medical device in Germany needs more than just a CE marking. Intended use, classification, conformity assessment, registration, and deadlines are all interconnected and determine when sales can actually begin. Life Sciences Law supports manufacturers, authorized representatives, importers, and start-ups with regulatory advice and structured project management from initial classification to market launch.
What makes market entry in Germany challenging
The German market for medical devices is one of the most attractive in Europe and, at the same time, one of the most heavily regulated. The European Medical Device Regulation (Regulation (EU) 2017/745, MDR) is the primary governing legislation, supplemented by the German Medical Devices Law Implementation Act (MPDG) and numerous harmonized standards. Further regulations include those arising from the German Act on Advertising of Therapeutic Products, competition law, data protection law, and, where reimbursement is involved, social security law.
For companies, this means that market entry is not a single regulatory step, but a project with many dependencies. An incorrectly formulated purpose declaration can shift the risk classification, a late application to the notified body can delay the market launch by months, and incomplete technical documentation can halt an ongoing process. Companies from abroad launching their product in the European Economic Area for the first time, as well as young MedTech companies without their own regulatory affairs department, are particularly affected.
This is precisely where the consultation comes in: Legal classification and operational project management are brought together so that regulatory requirements do not only become apparent when they jeopardize the schedule.
Are you planning a market launch in the coming months? Clarify the regulatory situation before committing to dates with investors or distribution partners.
Consulting and project management for market access: the services
Life Sciences Law accompanies companies throughout the entire market entry process. Its consulting services combine legal review with a project-oriented approach that clarifies responsibilities, milestones, and deadlines. The scope of services is tailored to the product's maturity level, the company's size, and available internal resources.
Regulatory assessment and gap analysis
The first step is a thorough inventory. This includes examining the intended purpose, classifying the product as a medical device, in-vitro diagnostic, medicinal product, or cosmetic, classifying it according to Annex VIII of the MDR, and reviewing the existing documentation. The result is an overview of which evidence is already sufficient and where gaps exist.
This analysis forms the basis of any realistic timeline. It prevents a project from being based on assumptions that would not stand up to scrutiny in the conformity assessment process.
Project planning with a reliable timeframe
The gap analysis results in a project plan with clearly defined work packages, responsibilities, and deadlines. This plan takes into account factors such as the capacity of the notified body, the time required for clinical data, coordination with suppliers and contract manufacturers, and the internal approval chain. For companies without their own regulatory affairs structure, Life Sciences Law coordinates the participating service providers and departments.
Key components include:
- Milestone planning: Intermediate targets are defined in such a way that delays are recognizable early on and do not only become apparent shortly before the planned market launch.
- Deadline monitoring: Regulatory deadlines, certificate validity periods and internal deadlines are kept in a common calendar and continuously monitored.
- Interface management: Development, quality management, marketing, sales and external consultants all work with the same level of information.
- Document control: Technical documentation, contracts and evidence are structured in such a way that they can be submitted to the notified body and authorities at any time.
- Escalation paths: For critical issues such as queries from the notified body or supplier problems, it is determined in advance who will decide.
Strategic consulting for management and investors
Regulatory decisions are business decisions. Whether a product initially launches in a lower risk class with a limited purpose or directly targets a broader medical indication impacts development costs, time-to-market, and valuation. Life Sciences Law legally classifies these options and makes the economic consequences transparent, also for supervisory boards, investors, and due diligence processes.
Before finalizing a product strategy: Have the regulatory consequences of the planned intended use examined.
Purpose and classification as the first step
The intended purpose determines whether a product qualifies as a medical device and which requirements apply. This purpose is derived from the manufacturer's information in the labeling, instructions for use, and advertising materials. Even a single phrase on a website can place a wellness product within the scope of the MDR (Medical Device Regulation) or, conversely, render a medical claim inadmissible.
The classification according to Annex VIII of the MDR then determines the path through the conformity assessment. The risk class determines whether a notified body must be involved, the scope of the technical documentation, and the complexity of the clinical evaluation. Classification is particularly challenging for software and digital applications because the distinction between medical devices, digital health applications, and purely lifestyle products is often blurred.
Typical borderline cases involve combination products of active ingredient and carrier, aesthetic products, accessories for medical devices, and applications using machine learning algorithms. In all these cases, it is worthwhile to provide a documented justification for the chosen classification that will stand up to scrutiny from authorities and notified bodies.
Unsure whether your product falls under the MDR? Early classification costs significantly less than a later correction.
Conformity assessment, notified body and CE marking
No medical device may be placed on the market without a successful conformity assessment. Depending on the risk class, the manufacturer carries out the procedure independently or involves a notified body. Among other things, compliance with the essential safety and performance requirements according to Annex I of the MDR, a quality management system, systematic risk management, and a clinical evaluation demonstrating safety and performance must be proven.
The capacity of notified bodies is a real bottleneck. Inquiries, contract conclusion, preliminary review, and audit planning take considerable time, sometimes well over a year. Anyone who only makes contact once the documentation is complete wastes time. Conversely, incomplete submissions lead to follow-up cycles that further prolong the process.
Life Sciences Law provides support in selecting and contractually aligning with the notified body, in reviewing technical documentation for regulatory completeness, and in communication throughout the ongoing process. The goal is a process with as few rounds of follow-up requests as possible.
Plan your initial contact with the notified body well in advance. The timing of the inquiry often determines the market launch date.
Keep an eye on deadlines: the critical cut-off dates
Deadlines are not a peripheral issue in medical device law, but a key risk factor. If a deadline is missed, a product may lose its marketability, even if it remains technically safe. Therefore, structured deadline management is essential in every market entry project.
Transitional periods for existing products
For products still based on certificates issued under the previous directives, staggered transition periods apply. According to amending Regulation (EU) 2023/607, Class III products and certain implantable Class IIb products may continue to be placed on the market under the old legislation until December 31, 2027 at the latest. Other Class IIb and IIa products, as well as Class I products placed on the market sterile or with a measuring function, may continue to be placed on the market until December 31, 2028 at the latest. However, this extension is subject to certain conditions, in particular an MDR-compliant quality management system and a timely contract with a notified body. The current legal status is always decisive. Furthermore, the European Commission presented a proposal for the revision of the MDR and IVDR in December 2025, which is currently undergoing legislative consideration. Whether and in what form this will result in any simplifications remains to be seen, which is why companies should continue to base their planning on the applicable deadlines.
Registration, EUDAMED and reporting obligations
Manufacturers, authorized representatives, and importers must register and mark their products with a unique product identifier. Since May 28, 2026, the use of the first four modules of the European database EUDAMED has been mandatory: actor registration, UDI and product registration, notified bodies and certificates, and market surveillance. Product registration is not possible without the Single Registration Number (SRN) issued in the first module. Products already on the market before this deadline must be registered retroactively within the six-month transition period, i.e., by the end of November 2026. In Germany, the previous recording of product notifications and certificates in the national DMIDS system will be discontinued. In practice, missing or late registrations often only come to light during market surveillance measures and then lead to distribution interruptions.
Internal deadlines in the project
In addition to legally mandated deadlines, internal deadlines are crucial for success. These include certificate validity periods, audit cycles, contract durations with manufacturers and suppliers, validity periods of test reports, and the update intervals for clinical evaluations. Centralized management of these deadlines allows bottlenecks to be resolved early on.
Is a certificate expiring within the next 18 months? Start the transition now, not in the last quarter of the term.
German peculiarities: MPDG, roles and language
The MDR applies directly in all member states, but in Germany it is supplemented by the MPDG. The MPDG regulates, among other things, the responsibilities of the authorities, the procedures for clinical trials, notification obligations, and fines and criminal offenses. Anyone targeting the German market must consider this national level of regulation.
Roles along the supply chain
The MDR distributes responsibilities among several economic operators. Manufacturers bear the primary responsibility for conformity, documentation, and market surveillance. Companies based outside the European Union require an authorized representative within the Union, whose duties should be clearly defined by contract. Importers and distributors have their own testing and documentation obligations and can themselves be considered manufacturers in the event of violations, for example, if they offer a product under their own name or substantially modify it.
The contractual structuring of these relationships is a frequently underestimated lever. Sales, distribution, and agency agreements should precisely define responsibilities, reporting channels, liability, and the consequences of termination.
Responsible person according to Article 15 MDR
Manufacturers and authorized representatives must have a person responsible for regulatory compliance. This role requires specific qualifications and can, under certain conditions, be filled externally. In practice, it is crucial that the role is defined by sufficient authority and documented in a traceable manner.
Language, labeling and instructions for use
For the German market, labeling and instructions for use must be provided in German. Translations are not merely a linguistic issue: Incorrect wording can alter the intended purpose, invalidate warnings, or create liability risks. Therefore, a legal review of all market-related documents should be part of the preparation for the market launch.
Before launching sales in Germany: Have the labeling, instructions for use and distribution agreements checked for compliance with national requirements.
From market access to market control: distribution, reimbursement and advertising
The CE marking grants legal access to the market, but it does not guarantee commercial success. Whether a product actually reaches the user depends on the chosen distribution channel and its eligibility for reimbursement. Depending on the product, options include inclusion in the medical aids directory, integration into hospital reimbursement systems, contracts with health insurance providers, or distribution as a digital health application.
These questions should be asked early because they have a direct impact on product development. The evidence a funding body expects differs from what is sufficient for CE marking. Considering both requirements together avoids duplicate studies and wasted time.
Strict rules apply to communication in this area. The German Act on Advertising of Therapeutic Products (Heilmittelwerbegesetz) imposes different limits on statements made to professionals and laypersons, competition law penalizes misleading information, and the Medical Device Regulation (MDR) prohibits advertising claims that go beyond the intended purpose. Websites, product brochures, trade fair appearances, and social media content should be reviewed before market launch.
Before the launch campaign goes live: Have claims and product communication legally approved.
Post-market surveillance and vigilance
With market launch, ongoing regulatory responsibility begins. Manufacturers must maintain a post-market surveillance system, systematically analyze data, prepare safety reports, and report serious incidents. For higher-grade products, regular updates to the clinical evaluation and measures for clinical follow-up are also required.
The situation becomes critical when an authority takes action or a recall is imminent. In such cases, swift decisions, thorough documentation, and coordinated communication with authorities, customers, and the public are essential. Life Sciences Law provides legal and strategic support in these situations, assisting with statements, corrective measures, and internal investigations.
Have you received a report of an incident? Clarify reporting obligations and deadlines before communicating with customers.
Typical mistakes when entering the market and how to avoid them
Recurring patterns emerge from the support provided for market entry projects. These typically cost not only money, but above all, time.
- Fundamental questions raised too late: Classification and intended purpose will only be clarified after development is complete, so improvements will delay the entire schedule.
- Underestimated capacity bottlenecks: The search for a notified body only begins late, although lead times of many months are common.
- Incomplete clinical data: Existing literature does not support the claimed purpose, a fact that only becomes apparent during the proceedings.
- Unresolved role distribution: Contracts with agents, importers and dealers do not clearly regulate regulatory obligations.
- Advertising promise: Marketing material promises effects that are not covered by the intended purpose.
- Forgotten follow-up obligations: After the market launch, monitoring, reporting channels and documentation updates are not consistently implemented.
A structured project with clear responsibilities and ongoing deadline monitoring prevents most of these errors from occurring in the first place.
Submit your inquiry now
We will gladly advise you comprehensively and personally on your request.
Submit your inquiry now
We will gladly advise you comprehensively and personally on your request.
Your contact person for the market entry of medical devices
Life Sciences Law is the law firm of attorney Ralph Schäfer, based in Starnberg near Munich, specializing in advising clients in the pharmaceutical, biotech, medtech, healthcare, and aesthetic medicine sectors. Ralph Schäfer has been a licensed attorney for 27 years and during this time has held positions including General Counsel, Compliance Officer, and board member in international, publicly listed life sciences companies.
This combination results in consulting services that don't consider regulatory requirements in isolation, but rather integrate them into development, sales, and business processes. The range of services extends from the initial classification of a product and support throughout the conformity assessment process, to contract drafting along the supply chain, review of product communication, and representation before authorities and notified bodies. Upon request, Life Sciences Law also assumes project management and collaborates with the technical and clinical service providers involved in your project.
Are you planning to launch a medical device in Germany or are you already in the middle of the process? Get in touch and secure your timeline.
FAQs: Frequently asked questions about market entry of medical devices
The product must comply with the requirements of the MDR, have undergone a conformity assessment procedure, and bear a CE marking. In addition, a quality management system, complete technical documentation, a clinical evaluation, and registration of both the manufacturer and the product are required. For the German market, the labeling and instructions for use must also be provided in German.
The duration depends heavily on the risk class and the maturity of the documentation. Products in lower risk classes, without the involvement of a notified body, can be marketed within a few months. For higher-risk products, timeframes of one to three years are realistic, with the availability of the notified body and the clinical data being the most significant influencing factors.
Unlike pharmaceuticals, medical devices do not undergo formal regulatory approval. Market access is granted through conformity assessment and CE marking, a process in which a notified body participates depending on the risk class. Authorities such as the BfArM (Federal Institute for Drugs and Medical Devices) and state authorities are primarily involved in clinical trials, registrations, vigilance reporting, and market surveillance.
Project management translates regulatory requirements into work packages, deadlines, and responsibilities. It ensures that development, quality management, clinical evaluation, contract drafting, and market communication are coordinated. The practical benefit lies in identifying bottlenecks such as notified body capacity or missing documentation early on, rather than discovering them shortly before the planned market launch.
For products with certificates issued under the previous directives, staggered transition periods apply until the end of 2027 or the end of 2028, depending on the risk class. The extension is only granted under certain conditions, in particular with an MDR-compliant quality management system and a timely contract with a notified body. Since a revision of the MDR and IVDR is currently being discussed in the European legislative process, the current status should be checked for each product individually.
Manufacturers without a registered office in the European Union must appoint an authorized representative within the Union to assume certain regulatory responsibilities. The contract with the authorized representative should precisely define their duties, information flows, liability, and the consequences of termination. Additionally, importers and distributors in the supply chain must be included, as they have their own verification and documentation obligations.
Software is considered a medical device if, according to the manufacturer's intended purpose, it serves medical purposes, such as diagnosis, monitoring, prediction, or treatment. Purely documentation, administrative, or fitness applications generally do not fall under this category. The distinction can be complex in individual cases and should be documented and justified, as it determines the risk classification and the required level of proof.
Reimbursement often determines whether a product is actually used. Depending on the application, options include the medical aids directory, inpatient reimbursement systems, selective contracts, or the use of a digital health application. Since payers require different documentation than conformity assessment, the reimbursement strategy should be developed in parallel with regulatory planning.
Authorities can request documents, conduct inspections, issue sales bans, or order recalls. Crucially, a swift, documented response, a reliable risk assessment, and coordinated communication are essential. Those who have predefined reporting channels, responsibilities, and procedures can act much more effectively in such situations.
Early involvement is advisable, ideally before defining the intended purpose and before making commitments to investors or distributors. It is equally important in borderline classification cases, supply chain contracts, disputes with notified bodies, and regulatory actions. Early consultation reduces risks and, above all, protects the timeline.
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Your law firm LIFE SCIENCES LAW - Ralph Schäfer – Lawyer.
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- ralph.schaefer@lifescienceslaw.de
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