Friday, December 31, 2021

EU MDR Economic Operators

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 EUDAMED

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 Economic Operators.

Let’s discuss in detail about the requirements of Economic Operators.

ECONOMIC OPERATORS

In EU MDR 2017/745, a Manufacturer, authorized representative, importer, distributor and persons referred in article 22(1) & 22(3) are considered as Economic Operators.

Let’s discuss in detail about each of the Economic Operators.

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MANUFACTURER

The Manufacturer is a natural or legal person or an entity who manufacturers or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets the device under its name or trademark.

Article 10 – General Obligations of Manufacturers, states the requirements for Manufacturer.

Here are few of the basic responsibilities of Manufacturer’s:

1. Responsible for Clinical Evaluation and Post Market Surveillance system.

2. Responsible for establishing & maintaining the Technical Documentation for each product/product family.

3. Responsible for establishing agreements & communication channels with other Economic operators.

4. Pre-market classification & registration of the device manufactured.

5. Responsible for satisfying the UDI System requirements as per EU MDR 2017/745.

6. Responsible for Post Market Clinical Follow up.

AUTHORIZED REPRESENTATIVE

The Authorized Representative is a natural or legal person or an entity established within the European Union who has received and accepted a written mandate to act on behalf of the foreign manufacturer who is located outside the European Union, with respect to the Manufacturer’s legal obligations under this regulation.

Article 11 – Authorized Representative, states the requirements for Authorized Representatives.

Here are few of the responsibilities of Authorized Representative:

1. The Authorized Representative is jointly responsible for Defective Medical Device Placed in the European Union Market.

2. To fulfill the requirements & obligations as per its agreements with Manufacturer.

3. To make sure the availability of Product Technical Documentation, registration details and other certificates in its registered location or whenever asked by the relevant regulatory authorities.

4. Responsible for communication with Competent Authorities & other relevant regulatory authorities.

5. Provide immediate and timely update to the manufacturer regarding the complaints and reports of incidents with respect to the device placed in European Market.

IMPORTER

The Importer is a natural or legal person or an entity established within the union who places a device from a third country on the Union Market.

Article 13 – General Obligations for Importers, states the requirements for Importer.

Here are few of the responsibilities of Importers:

1. Responsible for UDI requirements of the device, need to ensure whether the manufacturer has satisfied all the requirements of UDI as per EU MDR 2017/745.

2. To verify whether the device is properly labelled and provided with all the supporting documents like Instructions for use, user manuals etc.

3. Establish and maintain communication channels with the manufacturer.

4. To maintain a register for product complaints and other non-conformities.

DISTRIBUTOR

The Distributor is a natural or legal person or an entity in the supply chain, other than the manufacturer or the importer, who makes the device available on the market, up until the point of putting into service.

Article 14 – General Obligations for Distributor, states the requirements for Distributor.

Here are few of the responsibilities of Distributors:

1. To ensure safe storage and transportation of Medical Device.

2. To establish and maintain communication channels with manufacturer, authorized representative, importer to inform about complaints, feedback from clinicians and other non-conformities.

3. Responsible for traceability of the product.

4. Responsible for Product recalls & advisory notices.

Apart from above mentioned Economic Operators, persons referred in Article 22(1) & Article 22(3) will also be considered as an Economic Operator.

ARTICLE 22(1)

Natural or legal persons who combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:

(a) other devices bearing the CE marking;

(b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;

(c) other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.

ARTICLE 22(3)

Any natural or legal person who sterilises systems or procedure packs referred to in paragraph 1 for the purpose of placing them on the market.

Now I hope you have acquired some knowledge about EU MDR 2017/745 Economic Operators. 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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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

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.