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

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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