Legal department
In hardly any other industry are the legal requirements and regulatory hurdles as high as in in-vitro diagnostics. Specific legal requirements apply at every stage of development and even after the product has been placed on the market. There are often seemingly conflicting interests and there is a risk of getting lost in the complexity of the legal regulations. The VDGH wants to be a reliable partner for its members, is committed to reducing excessive bureaucracy and calls for legislation that always has the interests of the industry in mind.
Legislation
The VDGH sees it as one of its main tasks to represent the interests of its members. By closely monitoring the current legal situation, recommendations and advice can be given to members at an early stage. However, new laws can also restrict or curtail interests. Legislators do not always fully recognize the needs of practitioners. This risk should be reduced or even avoided by submitting comments on draft legislation. As a central point of contact for political decision-makers, the VDGH is generally involved in the processes at an early stage and can thus incorporate the interests of in-vitro diagnostics into the respective procedures at national and, above all, European level.
The diversity of member companies ranges from SMEs to global players on the market.
Data protection
The daily processing and use of data is already part of our everyday lives and will become even more important in the future. In this context, the requirements for data protection and data security must also continue to increase. It should be noted that the two terms should not be used synonymously. While data protection deals with the "when" and "how" of data processing, data security is about protecting data from unauthorized access.
Data protection describes the protection against improper processing of personal data as well as the protection of the right to informational self-determination. Data protection deals with the protection of personal data from unauthorized collection, processing and disclosure. It safeguards the individual's right to informational self-determination. The focus here is on information that is directly or indirectly related to a specific person.
The VDGH sees a tension between the interest in the use of data, particularly in the area of research and development, and the protection of individuals against the misuse of their personal data. These opposing poles must be taken into account and weighed up against each other in the question of permissible data processing.
Compliance
The VDGH Code for In-vitro Diagnostics and Medical Devices(VDGH Code) came into force on July 1, 2021. The decision of the German Federal Cartel Office to recognize the VDGH Code as a competition rule was published on 20 January 2022. The VDGH is thus taking into account the increased expectations of its member companies for an ethical industry. Compliance with applicable laws and guidelines and adherence to ethical standards are both an obligation and an essential step towards a balanced regulatory environment, while at the same time promoting the reputation and success of companies.
The VDGH is planning to set up a Compliance Committee to monitor compliance with the resulting obligations and offer member companies a point of contact in the event of violations.
The committee will advise on processes to be improved and the introduction of guidelines as well as discuss compliance issues identified in various areas and countries. The committee can play an important role in solving compliance problems, particularly in crisis situations.
As a member of MedTech Europe, the VDGH is also subject to the MedTech Europe Code of Ethical Business Practice. For VDGH member companies that are not members of MedTech Europe, the Code is implemented by the VDGH Code, taking into account the German legal situation and case law.