Conformity of Medical Device Regulation in Health Technology Company
Hartikainen, Minna (2020)
Hartikainen, Minna
2020
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-2020052915322
https://urn.fi/URN:NBN:fi:amk-2020052915322
Tiivistelmä
Medical devices are regulated in Europe by a new law from 26.5.2017 onwards. The name of the law is Medical Device Regulation (EU) 2017/745, MDR for short. The goal of this Master’s thesis was to provide the case company with recommendations on the actions that have to be taken to comply with the requirements set forth in the law, so that sales in Europe can continue when the transition period of the previous directive ends.
The research was carried out by analysing the current state of the company; what had already been done for MDR. After this, recommendations were created for fulfilling the requirements that still required actions. The recommendations were evaluated by 12 specialists working in the company, and they were updated based on these evaluations.
The theory section of this thesis is a comprehensive information package on the new regulation. It provides information about its effects on different stages of the approval process, for example quality management, risk management, incident reporting, UDI, and post-market surveillance systems. In addition, the new requirement on the person responsible for regulatory compliance and the new European electronic database (Eudamed) are described. The recommendations and their evaluation are described in the practical section.
The actions taken based on the evaluated recommendations, which are the final results of this research will eventually be audited by a notified body. This may affect the recommendations by making them even more comprehensive. However, the recommendations presented in this thesis are a good basis for fulfilling the requirements set forth in the new regulation. Because of the new law, fulfilling the requirements will be more time-consuming than before, and the need for documentation will increase. Special emphasis is given on the increased requirements for the risk management system and clinical evaluations throughout the life cycle of the product.
The Commission’s goal for the regulation is to remove the room for interpretation from the legislation, meet the challenges of developing technology, exclude problems that had occurred in use, improve safety and people’s health and support the functioning of the internal market while also maintaining the spirit of innovation. With the help of the recommendations, the case company can for their part help the Commission to reach this goal.
The research was carried out by analysing the current state of the company; what had already been done for MDR. After this, recommendations were created for fulfilling the requirements that still required actions. The recommendations were evaluated by 12 specialists working in the company, and they were updated based on these evaluations.
The theory section of this thesis is a comprehensive information package on the new regulation. It provides information about its effects on different stages of the approval process, for example quality management, risk management, incident reporting, UDI, and post-market surveillance systems. In addition, the new requirement on the person responsible for regulatory compliance and the new European electronic database (Eudamed) are described. The recommendations and their evaluation are described in the practical section.
The actions taken based on the evaluated recommendations, which are the final results of this research will eventually be audited by a notified body. This may affect the recommendations by making them even more comprehensive. However, the recommendations presented in this thesis are a good basis for fulfilling the requirements set forth in the new regulation. Because of the new law, fulfilling the requirements will be more time-consuming than before, and the need for documentation will increase. Special emphasis is given on the increased requirements for the risk management system and clinical evaluations throughout the life cycle of the product.
The Commission’s goal for the regulation is to remove the room for interpretation from the legislation, meet the challenges of developing technology, exclude problems that had occurred in use, improve safety and people’s health and support the functioning of the internal market while also maintaining the spirit of innovation. With the help of the recommendations, the case company can for their part help the Commission to reach this goal.