European medical device regulating authority, the European Commission, issued two additional guidance. They expand on certain application aspects of Medical Device Regulation and in vitro Diagnostic Device Regulation. The new documents include important changes and additional requirements for the parties involved in the regulatory process.
New amendments deal with the following issues:
- The appointment of person responsible for regulatory compliance
- Filing the Implant Card
Novelties in details
According to the new requirements, companies would be obliged to appoint a person to be responsible for regulatory compliance.
The guidance specifies that the appointed person should have relevant education in the form of degree in one of the following fields:
- Other suitable scientific discipline.
This person should also have at least four years of professional experience in the quality management of medical devices. The responsible person should have an in-depth connection with manufacturing process in order to ensure the compliance of all the required applicable processes and procedures. At the same time, regulating authority will allow small enterprises to make some kind of “outsourcing”; meaning they will be able to engage the responsible person as a subcontractor. In order to participate in this exclusion, the company should have the annual turnover less than 10 million euro and the total number of employees should be less than 50.
If the company meets the requirements listed above, it can subcontract the person that meets the applicable requirements as the person responsible for regulatory compliance, unless that person is the official representative of the company; it is forbidden to appoint one person on these two positions.
The idea of appointing a person to be responsible for regulatory compliance seems to look similar to the appointment of Data Protection Officer in accordance with the GDPR. The main goal is to improve the level of control and safety in the appropriate fields in both two cases. The appointment of the responsible person will help to simplify the compliance assessment system and the whole regulatory process in general, since only one person will communicate with regulatory authority and be responsible for all regulatory issues.
The second document covers the issues related to the Implant Card. According to the Article 18 of the Medical Device Regulation, Implant Card should contain the following important information on particular medical device:
- The name of the devices
- Serial number
- UDI code (unique device identification)
- The type of the device
- The information on the manufacturer of the medical device including name, address and website.
New guidance specifies additional requirements to the information provided with the devices. For example, printed documentation supplied with the device should contain information of all symbols used. The language of the information will depend on the particular state where the device would be distributed or used. To assist companies with the implementations of the requirements listed herein, the regulating authority attached a list of symbols and examples of Implant Cards to be used for the development of own ones.
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