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LIFE SCIENCES LAW – Ralph Schäfer – Lawyer – Your partner for legal issues in the life sciences industry
Medical Device Law – Legal Advice for MedTech Companies, Manufacturers, Distributors and Start-ups
Medical Device Law Attorney Munich
Navigating medical device law – legally compliant, practical, strategic
Medical device law forms the central regulatory framework for the development, manufacture, approval, CE marking, and monitoring of medical devices in Europe. In the highly dynamic MedTech environment, regulatory requirements determine not only market access and compliance, but also directly impact economic success, innovation, and patient safety.
Life Sciences Law supports manufacturers, distributors, authorized representatives, dealers, startups, clinics, and digital healthcare providers in legally implementing the complex requirements of the Medical Device Regulation (MDR), the German Medical Devices Ordinance, and the German Medical Devices Law Implementation Act (MPDG). Their consulting services combine legal precision with many years of practical experience in MedTech and life sciences.
Services in medical device law
The European MDR regulation has fundamentally changed medical device law. Higher requirements for clinical evaluations, stricter conformity assessment procedures, more documentation obligations, vigilance requirements, and significantly more intensive market surveillance demand a structured, professional approach to regulatory issues.
Life Sciences Law offers support that combines regulatory requirements with the actual processes in MedTech companies. This results in solutions that are legally sound, economically viable, and implementable in day-to-day business – regardless of whether it concerns CE marking of new products, MDR certification, or ongoing compliance.
Classification, conformity and CE marking
Correct classification is the foundation of every medical device and influences the risk class, documentation requirements, testing obligations, and the involvement of the notified body. It is therefore the crucial step for a successful conformity assessment according to the MDR.
Important topics include:
- Risk classes and distinction between pharmaceuticals, cosmetics and medical devices
- Conformity assessment, essential safety requirements and Annex I MDR
- technical documentation, risk management and CE marking
- Cooperation with the notified body and preparation of the declaration of conformity
I will support you in defining the appropriate regulatory path and in structuring technical documentation in such a way that CE marking is achieved in a legally compliant, complete and efficient manner.
This helps you avoid delays and creates clarity early on for development, strategy and market entry.
Quality management, manufacturing and design control
An effective quality management system is essential for the safe development and production of medical devices. Topics such as good manufacturing practices in medical technology, auditability, and process validation also play a crucial role.
This includes in particular:
- Quality management according to ISO 13485 and requirements of the MPDG
- Design Control – from idea to validation, throughout the entire product lifecycle
- Audit preparation and regulatory process safety
Together we ensure that your processes are regulatory-compliant, yet remain pragmatic and can be implemented efficiently in day-to-day business.
Clinical evaluation, clinical trial and PMCF
The MDR places high demands on clinical data that demonstrate a product's safety and performance. CE marking is not possible without a sound clinical evaluation.
Key components include:
- Clinical evaluation according to MDR and MPDG
- Planning and legal support for clinical trials, including ethics committee
- PMCF strategies, post-market clinical follow-up and continuous data updates
I ensure that clinical evaluations are structured, complete and regulatory-compliant – a crucial factor for successful CE marking.
Identification, traceability and EUDAMED
Transparent product information and complete traceability are key requirements of the MDR.
Particularly relevant are:
- UDI system, product labeling and traceability
- Labels, IFUs and language requirements
- Obligations and entries in the EUDAMED database
I will review your labeling documents and support you in their implementation, ensuring that product information is reliable, complete and legally compliant.
Post-market surveillance, vigilance and market monitoring
The ongoing regulatory responsibility of a medical device begins after it has been placed on the market.
This includes:
- PMS concepts and vigilance reports
- Assessment of incidents
- Risk-based trend analyses and corrective measures
I will support you in establishing a robust monitoring system and in reacting quickly, professionally and in compliance with regulations in an emergency.
Actors, responsibilities and regulatory roles
The MDR sets clear obligations for all economic operators – manufacturers, PRRCs, importers, distributors and authorized representatives.
Relevant factors include:
- Person Responsible for Responsibility (PRRC) and Internal Responsibilities
- Manufacturer obligations under MDR and MPDG
- Obligations of importers, dealers and authorized representatives
- clear organization and compliance along the supply chain
Together we create a transparent, legally compliant structure that clearly defines responsibilities and reduces risks along the supply chain.
Borderline cases, digital medical devices and special issues
Innovative technologies often lead to regulatory demarcation issues – especially in the case of software, AI, or aesthetic products.
Typical topics include:
- Software as a medical device and its distinction from wellness or lifestyle apps
- DiGA approval, digital health applications, IVDR requirements
- aesthetic products, borderline cosmetic cases and combination products
I will help you to correctly classify your product and define the regulatory requirements early on in order to avoid later conflicts.
Marketing, advertising and HWG compliance
Advertising for medical devices must be legally permissible and effective. In addition to the MDR (Medical Device Regulation), the German Act on Advertising of Therapeutic Products and competition law play an important role.
The following aspects play a role:
- Legally compliant advertising statements and permissible claims
- Distinguishing between advertising to professionals and advertising to the general public
- digital sales, online marketing and social media
- Avoiding misleading advertising and greenwashing
You will receive clear recommendations to ensure that your communication remains legally compliant while effectively addressing your target audience.
Administrative procedures, risk management and enforcement
Regulatory conflicts, market surveillance measures or complaints require swift, strategic action.
The following is particularly important:
- Handling of market surveillance measures
- Official communications and statements
- Support with recalls and corrective actions
I will provide you with legal and strategic support to ensure that regulatory challenges are mastered confidently and the impact on your product portfolio is minimized.
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.
Why Life Sciences Law in medical device law?
Life Sciences Law Ralph Schäfer combines specialized legal advice with genuine leadership experience from the life sciences industry. Admitted to the bar for 27 years, he has held various roles as in-house and external legal counsel and business manager in international companies, including General Counsel and board member of a publicly listed biotech company, as well as in associations.
These include, among others:
- 10+ years as General Counsel and Corporate Counsel international, publicly listed medical technology, biotech and pharmaceutical company
- Long-standing responsibility in senior positions, long-time member of the management team, and as a board member of a listed biotech company, with a focus on law, compliance, strategy and regulation
- Extensive experience as a compliance officer of a publicly listed biotech company
- Extensive experience at the interface of pharmaceuticals, biotech, medtech and health care
- Solution finder, strategy partner and legal guide for executive and supervisory boards
This combination of legal expertise and operational management practice enables the firm to provide advice that is legally precise, economically viable, and practically implementable. The firm stands for personal, pragmatic, and ethically oriented support in the highly regulated life sciences environment.
FAQs – Frequently Asked Questions about Medical Device Law
Medical device law encompasses all requirements for the development, manufacture, conformity assessment, CE marking, marketing, and monitoring of medical devices. The central legal basis is the MDR Regulation and the German Medical Devices Law Implementation Act. The aim is to ensure safety, performance, and quality.
A medical device is a product intended for medical purposes, but whose primary effect is not pharmacological, immunological, or metabolic. Classification is based on its intended purpose, function, and presentation. This classification determines the regulatory pathway and the requirements of the MDR.
The MDR tightens clinical requirements, increases documentation obligations, strengthens market surveillance, specifies manufacturer obligations, and expands responsibilities for distributors, importers, and authorized representatives. Furthermore, stricter requirements for conformity assessment and CE marking must be met.
CE marking is affixed following a conformity assessment, the scope of which depends on the risk class. Technical documentation, clinical evaluation, risk analysis, and the involvement of a notified body (if required) are key components. Only after successful testing may the product be placed on the market.
The technical documentation forms the core of the regulatory evidence. It includes safety and performance data, clinical evaluations, risk management, instructions for use, and evidence of compliance with essential requirements. It must be complete, up-to-date, and readily available at any time.
Manufacturers bear the primary responsibility for safety, conformity, and documentation. Importers must verify that products from third countries comply with the MDR. Distributors must ensure that products are correctly labeled and accompanied. All stakeholders are subject to reporting and vigilance obligations.
The PRRC is the internal or external person responsible for ensuring compliance with regulatory obligations. They monitor, among other things, technical documentation, declarations of conformity, vigilance, and PMS processes. Companies without a PRRC risk significant penalties.
Clinical evaluation is mandatory for almost all medical devices. It is based on clinical data, literature review, and, in some cases, clinical trials. For higher-grade products, additional PMCF activities are often required.
After market entry, manufacturers must maintain a product management system (PMS), report incidents, prepare safety reports, and initiate corrective actions as needed. These monitoring obligations are ongoing and crucial for product safety.
Support is particularly important for classification issues, CE marking processes, coordination with notified bodies, clinical evaluation, vigilance matters, recalls, advertising and marketing authorization issues, complex conformity requirements, or regulatory actions. Early consultation reduces risks and accelerates regulatory processes.
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Your law firm LIFE SCIENCES LAW - Ralph Schäfer – Lawyer.
- +49 8151 4466683
- ralph.schaefer@lifescienceslaw.de
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Munich Street 33
82319 Starnberg