Tuesday, December 14, 2021

EU MDR EUDAMED

Hi friends!!!


In our previous blog, we have discussed about the following topics.


EU MDR Assessment Routes


EU MDR Timeline, Annex, Chapter


EU MDR Post Market Surveillance


EU MDR Clinical Evaluation


EU MDR Technical Documentation - Part 1


EU MDR Technical Documentation - Part 2


EU MDR General Safety and Performance Requirement


EU MDR Information on the Label


EU MDR Post Market Clinical Follow Up


EU MDR Unique Device Identification - Part 1 


EU MDR Unique Device Identification - Part 2


EU MDR Classification Rules


EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe. 


Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 requirements for EUDAMED European Database on Medical Devices.


Let’s discuss in detail about the requirements of EUDAMED European Database on Medical Devices.

 

EUDAMED is a European Database on Medical

Devices


EUDAMED is a public database that provides health and safety information for medical devices. EUDAMED stores and provides access to specific data including medical device identification, adverse events and certification information.


In EU MDR 2017/745 Article 33 provides requirements for EUDAMED.



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ARTICLE 33 EUROPEAN DATABASE ON

MEDICAL DEVICES

 

1. The European database on medical devices EUDAMED was setup for the following purposes:


To enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators.

To enable unique identification of devices within the internal market and to facilitate their traceability.

To enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant to Article 81;

To enable manufacturers to comply with the information obligations laid down in Articles 87 to 90 or in any acts adopted pursuant to Article 91;

To enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them.

 

2. EUDAMED shall include the following electronic systems:


- The electronic system for registration of devices referred to in Article 29(4).

- The UDI-database referred to in Article 28.

- The electronic system on registration of economic operators referred to in Article 30

- The electronic system on notified bodies and on certificates referred to in Article 57.

- The electronic system on clinical investigations referred to in Article 73.

- The electronic system on vigilance and post-market surveillance referred to in Article 92.

- The electronic system on market surveillance referred to in Article 100.

 

3. The data shall be entered into Eudamed by the Member States, notified bodies, economic operators and sponsors as specified in the provisions on the electronic systems referred to in paragraph 2. The Commission shall provide for technical and administrative support to users of Eudamed.


4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2.


5. Eudamed shall contain personal data only insofar as necessary for the electronic systems referred to in paragraph 2 of this Article to collate and process information in accordance with this Regulation. Personal data shall be kept in a form which permits identification of data subjects for periods no longer than those referred to in Article 10(8).


6. The Commission and the Member States shall ensure that data subjects may effectively exercise their rights to information, of access, to rectification and to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall also ensure that data subjects may effectively exercise the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data are deleted, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, but no later than 60 days after a request is made by a data subject.


Now I hope you have acquired some knowledge about EU MDR 2017/745 EUDAMED. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


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