Regulatory affairs for medical devices

Demarcation and classification reports

Medicines and medicinal products are regulated under different European frameworks. Directive 2001/83/EC (MPD) provides the regulatory framework for medicinal products, while Regulation (EU) 2017/745 (MDR) describes the regulatory basis for medicinal products. In the case of so-called borderline products, it is not clear from the outset which regulatory framework they fall under. In addition, there are combination products that must fulfil both the requirements of the MDR and those of the MPD. It is important to clarify which requirement is decisive for approval or certification and how the corresponding product can be qualified.

Benefit from our extensive experience in the field of medical devices and medicinal products: We support you in the decision-making process in questions of demarcation for your product and in the preparation of demarcation reports for submission to authorities or notified bodies.

Technical documentation

According to Annexes II and III of the MDR product dossiers contain all of the technical information about the medical device and a description of its manufacture and development. All data regarding intended use and information on product testing (preclinical and clinical) must be included in the technical documentation. We can create and update your technical documentation, conduct gap analyses and help you with our extensive experience to meet regulatory requirements.

Biological safety

The evaluation of biological safety is a main component of the essential requirements of medical devices. In addition to biocompatibility test results, you can also use and assess data and test results from the literature or clinical application.

We help you to create biological evaluation plans to find strategies, conduct literature research, toxicologic calculations and evaluate all relevant data on biocompatibility in the biological safety report.

Risk analysis

The risk analysis identifies hazards and enables an assessment of the risk based on available information and reasonably foreseeable scenarios. Biological and clinical risks are included in the analysis along with the hazards of improper use and technical factors.

For the successful development and certification of your drug product – especially with regard to biosafety and clinical safety – we prepare a well-founded risk management according to EN ISO 14971 to meet the requirements of the MDR. These go hand in hand with ensuring the safety of patients, users and third parties.

Clinical evaluation

can be evaluated using literature data or your own clinical tests.

We are happy to advise you which route is possible, feasible or necessary for your product and coordinate the procedure with you. Our experts conduct extensive literature research and can create both the clinical evaluation and clinical evaluation plan for you, as well as study concepts for clinical trials. PMCF studies are included.

Post-market clinical follow-up (PMCF) plans

One major element in proving the safety and efficacy of a medical device lies in the execution of studies, registers or user surveys of already certified medical devices. These proactive PMCF measures must be planned in compliance with the latest guidance documents and regulatory requirements.

We can support you with the preparation of PMCF plans and the corresponding study plans.

Support with certification

On request, we can also take over the following activities to build a solid base for your project:

• Contact with the notified bodies
• Preparation and implementation of a scientific consultation
• Support with certification
• Reviewing, optimising and preparation your documentation
• Development of your product