Today, the MDR (EU)2017/745 regulation has been fully implemented, but CE certificates issued in accordance with MDD 93/42/EC are still valid for the validity period indicated in the certificate. So as an enterprise holding MDD CE certificate, how to meet the annual supervision and audit under MDR regulations?
The transitional provisions of Article 120 of the MDR Regulations clearly state that some of the requirements of the MDR must be met even if a valid MDD CE certificate is held. In order to successfully pass the annual audit, the enterprise shall make appropriate amendments or additions to the system documents according to the following requirements. At the same time, given that the validity period of the MDD CE certificate shall not be later than May 27, 2024, enterprises should also prepare for the comprehensive upgrade of the ISO13485 system in advance to prepare for the subsequent application of the MDR CE certificate.
The following are the requirements that MDD CE supervision needs to meet under MDR regulations:
1. Major change requirements
If the device is modified, it should still meet the requirements of the MDD directive, and there should be no significant changes in design and intended use. In this regard, the MDCG(European Commission Medical Devices Coordination Group) has issued guidance document MDCG 2020-3, which companies should follow to carry out the change assessment process.
2. Post-market surveillance (PMS) requirements
2.1 A post-market surveillance report shall be prepared for a Class I device, summarizing the results and conclusions of the analysis of the data collected under the post-market surveillance plan, as well as the justification and explanation for any preventive and corrective actions taken. The report shall be updated as necessary and made available at the request of the competent authority.
2.2 Class IIa and above devices shall prepare periodic safety update reports (PSUR) summarizing the results and conclusions of the analysis of the data collected under the post-marketing regulatory program and providing justification and justification for any preventive and corrective actions taken.
PSUR renewal time: Class IIa devices should be renewed at least every two years when necessary, and Class IIb and III devices should be renewed at least annually.
3. Requirements for market surveillance activities
The competent authority should carry out appropriate checks on the conformity characteristics and performance of the device, including, where appropriate, review of documentation and physical or laboratory examination based on appropriate samples. Competent authorities should take into account, in particular, established principles relating to risk assessment and risk management, alert data and complaints. Competent authorities should establish an annual plan of regulatory activities and allocate a sufficient number of competent human and material resources to carry out those activities.
4. Warning system requirements
Manufacturers are required to report serious accidents and on-site safety corrective actions to the relevant authorities, and the reporting time limit has been updated as follows:
a) a serious threat to public health security - not later than two natural days after the threat is identified;
b) serious deterioration of the health condition of death or accident - not more than ten natural days from the date of discovery of the adverse event after the association between the medical device and the adverse event has been confirmed;
c) Other events - no more than fifteen natural days from the date of discovery of the event after the association between the medical device and the adverse event has been confirmed.
At the same time, the final report needs to be uploaded to the EUDAMED database.
5. Requirements of economic operators
The MDR has made clear the obligations of economic operators and also put forward higher requirements. At the same time, manufacturers, authorized representatives and importers shall bear the obligation to register in the EUDAMED database.
6. Device registration requirements
Before the device is placed on the market, it should be registered in the EUDAMED database. The registration should be submitted with company information and device-related information, including UDI information.
