The constant changes in the regulations for the approval of medical devices and medicinal products require the utmost attention and a permanent updating of the state of knowledge. This applies to both new product launches and the renewal of existing approvals. The market pressure for growth, innovation and regional expansion is creating increasing pressure on performance and resources. The overload on notified bodies is increased accordingly. A real game of nerves. Calmness, competence and goal-oriented work are currently the basic prerequisites for success.
To remain competitive in the market, manufacturers must have a profound knowledge of all applicable regulations and standards. In addition to this knowledge, it is also important to implement it on schedule. This is an ideal starting point for permanent or temporary external reinforcement.
The range of services and knowledge in the field of “Regulatory Affairs” is broad and touches on a multitude of different directives, laws, regulations and standards. At the same time, internationalization leads to a variety of country-specific regulations with explicit differences in approval.
Important regulations are national laws and ordinances such as the Medical Devices Act (MPG), the Medical Devices Operator Ordinance (MPBetreibV) or the German Medicines Act (AMG). Europe-wide guidelines for the approval of medical devices can be found in the Medical Device Directive and the Medical Device Regulation – MDR. In addition, the MEDDEV guidelines are an important requirement. In the European drug regulatory system, the approval of medicinal products is regulated either by a centralized, a decentralized or a mutual recognition procedure, in which EMA and the member states are responsible for the approval. Here, the requirements of the AMWHV must also be observed.
The core areas in this area are adaptations to the products as well as their labeling and testing prior to market launch. The creation and maintenance of technical documentation must comply with the requirements of the Medical Device Regulation (MDR) or the German Medicines Act (AMG) as well as the respective differences in international approvals. In addition to the FDA, the CFDA and PMDA must increasingly be taken into account here.
With our personnel and expert solutions, we help to solve resource bottlenecks to the point. With flexible experts on a temporary basis – or selected permanent employees who become part of the customer’s team structure.
Our service areas for fixed and flexible resource solutions:
- Development of an admission strategy taking into account all requirements (risk class, region)
- Risk analysis of the approval process taking into account all regulatory and normative requirements
- Creation and design of all information and forms relevant to the approval process
- Technical documentation
- Know-How in all regulatory requirements (AMG, MPG, MDR, MDD, AIMDD, MEDDEV, AMWHV, ISO 13485, ISO 14971, ISO 14155, ISO 20416, IEC 62366, IEC 62304)
- Development of the sequence and documentation structure for the approval process
- Review of country-specific regulations, requirements and processes with the relevant authorities in Europe, America (USA, Canada, Brazil), Asia (Japan, China, Taiwan, Korea) and Russia
- Review of civil and criminal product liabilities.
- Dovetailing with the areas of clinical studies, production, post-market surveillance (PMS) and quality management (interface management)
- Support of certification processes