Our focus: Medical devices
The regulatory requirements for the development, production, marketing and monitoring of classic medical devices including in-vitro diagnostics as well as digital health applications such as medical apps are complex and have been intensified since the European Medical Devices and In-vitro Diagnostics Regulation came into force. Manufacturers, as well as importers, distributors and suppliers, are required to ensure the safety and performance of their products throughout the supply chain. Our team offers support in all legal questions relating to the European MDR and IVDR regulations as well as national legislation. We advise industry players on the implementation of resilient compliance management systems, offering workable solutions for communication with notified bodies and market surveillance authorities, especially with respect to market measures and recall scenarios.
Our Healthcare team has been serving and advising industry players for over a decade and has extensive expertise in supporting manufacturers, distributors and suppliers of both analog and digital medical devices. Our support ranges from the drafting of legally compliant contracts to the implementation of complex compliance management systems and crisis management in worst-case scenarios.
- T + 49 30 / 2332 895 0
- E email@example.com
Head of Healthcare
- T +49 681 / 859 160 0
- E firstname.lastname@example.org
- T + 49 30 / 2332 895 0
- E email@example.com
The all-round carefree consulting package
The Health Care Department advises manufacturers of medical devices on legal issues relating to the European MDR and IVDR regulations, but also on the multitude of national regulations. Furthermore, we support:
- the qualification and classification of products (“genuine” medical devices vs. consumer products, “genuine” DiGaV-capable medical apps vs. wellness apps) and resulting demands for quality and risk management systems.
- the drafting of legally secure contracts with development service providers, suppliers and distributors that comply with both legal and regulatory requirements and the content of the industry-standard DIN ISO 13485, holding up to the scrutiny of notified bodies and market regulatory authorities.
- the implementation and review of compliance management systems through which manufacturers can identify gaps in existing systems and thus identify product safety risks and avoid liability risks.
- the evaluation of declarations of conformity, user information and marketing materials for products in order to protect against actions and warnings.
- the roll-out of necessary market measures and communication with authorities and customers in worst-case scenarios triggered by unsafe medical devices.
- the increasingly complex issues surrounding health data protection and cybersecurity with the experienced Digital Business Unit team at our disposal.
We assist our clients in all legal issues relating to medical devices. From development to monitoring. Nationally and internationally. Contact us!