The constant changes in the regulations for the approval of medical devices require the highest attention and a permanent update 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 creates increasing pressure on performance and resources. The overload of Notified Bodies has a correspondingly amplifying effect. Calmness, competence and goal-oriented work are currently the basic prerequisites for success.
To remain competitive in the market, manufacturers must have profound knowledge of all applicable regulations and standards. In addition to the knowledge, this must then also be implemented on schedule. An ideal starting situation for permanent or temporary external reinforcement.
The range of services and knowledge relating to the topic of “Regulatory Affairs” is broad and affects a large number of very 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) or the Medical Devices Operator Ordinance (MPBetreibV). 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.
The core fields in this area are adaptations to the products, their labeling and testing before market launch. The creation and maintenance of technical documentation must comply with the requirements of the Medical Device Regulation (MDR) and, if applicable, other CE directives, 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 resource solutions, we help solve project bottlenecks to the point. With flexible temporary experts – 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 (MPG, MDR, MDD, AIMDD, MEDDEV, 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