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R&Q's August 2020 webinar focused on Economic Operators: Addressing the EU MDR and IVDR requirements head-on. In this follow-up blog post, our knowledgeable MDR and IVDR regulatory experts sat down to answer audience questions.

See the Slides and Recording ➞

Under the new regulations, the requirements for the economic operators change significantly. The party that manufactures and markets the devices will need to drive these changes. The other economic operators will need to understand the regulations and be able to verify regulatory requirements, manage complaints, and cooperate with the Notified Bodies and Competent Authorities. Communication, accessibility, and established processes are keys to success. This on-demand webinar will help explain how the right framework will ensure that economic operators will be able to work together smoothly.

R&Q is here to help address any other questions that you may have regarding EU MDR and IVDR related topics. Contact us today to find out how we can help!
If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides).

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Q: Does the importer not provide the product to the end user? Just wondering what the difference is between importer and distributor?

A: The importer and manufacturer are the only economic operators who place product in the market. The distributor makes product available. As a manufacturer, you have the option of using the same entity to have the regulatory role of importer and distributor, but it is not required. For example, you may have one importer in the EU but have many distributors in the EU. Also note that per Article 31, the manufacturer and importer (and authorized representative) must have a SRN (single registration number).

Q: When we say "distributor", is it only direct distributor or all distributors in the supply chain until it reaches patients? Is the manufacturer expected to have quality agreements with all distributors in the supply chain?

A: The legal manufacturer is expected to have quality agreements with its direct distributors but should also request that the distributors in turn have quality agreements with any other distributors that are part of the supply chain.

Q: We work directly with exclusive distributors in some EU countries. Do we have to have an importer economic operator? Or are the distributors also acting as importers in these countries?

A: All product produced outside of the EU will be required to have a company with the importer regulatory role. A partner may be the importer, authorized rep, and distributor as long as they can meet the EU MDR regulatory requirements. It is up to the legal manufacturer to make sure the partner knows and can meet the regulatory requirements.

Q: Can the distributor and importer be the same? Can there be multiple importers?

A: The importer and distributor can be the same physical entity, but they must meet the regulations described by the EU MDR for both the importer and distributor regulatory roles. The legal manufacturer can make a business decision to have as many importers and distributors as they choose but it is inefficient. The MDR will require the importers to add information into EUDAMED.

Also, if there is a vigilance issue, the legal manufacturer will need to coordinate with all the importers, which can be burdensome. The “importer” means any natural or legal person established within the Union that places a device from a third country on the Union market. The “distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service.

Q: If the legal manufacturer is outside the EU but the location where the device is produced is within the EU, is an importer required?

A: When the legal manufacturer is outside of the EU but uses a contract manufacturer/critical subcontractor to build product on behalf of the legal manufacturer, the legal manufacturer must establish parties that meet the regulatory requirements of an authorized representative and importer.   The legal manufacturer is the natural or legal person who places the device on the market. All legal manufacturers outside of the EU must have an authorized representative and importer. The manufacturer, authorized rep, and importer all need to have a SRN (single registration number).

Q: How do you recommend having evidence on file to demonstrate the PRRC is fulfilling their responsibilities on a day-to-day basis?

A: Demonstrating that resources are competent is addressed by your Quality Management System (QMS). The best practice to demonstrate that the PRRC is fulfilling their responsibilities is to issue an internal memo identifying the PRRC and the responsibilities associated with the PRRC. There should be records in the quality system that are reviewed during routine audits that confirm if the PRRC is fulfilling their responsibilities. The PRRC will also demonstrate that they are fulfilling their responsibilities when they provide responses to the Notified Body (NB) or Competent Authority when requested for information. The role is new for the EU MDR, but demonstrating competency is covered by ISO 13485:2016.

Q: Is Importer name and address expected to be provided until the product reaches the end customer? Or only at the time of placing the device on the market? How are companies meeting this requirement especially when the information is provided in a document accompanying the device (and not part of product labeling)?

A: Per Article 13-3, the importer name and address are required to be on the device, its packaging, or in a document accompanying the device. The intent is that this information will be available to the end customer, but the regulation does not explicitly state this. There is no way to monitor the product after it leaves the supply chain.

Q: In case of devices which are supplied in non-sterile condition (implants) and are sterilized by hospital facilities; are they going to be the economic operator? Do they have any documentation requirements?

A: When the product is marketed and supplied as non-sterile to a hospital, the hospital is the customer, but not the economic operator. The legal manufacturer should provide direction on the best way to sterilize the device, which is no different than today.

Q: Should a critical supplier be considered an economic operator?

A: A critical subcontractor/contract manufacturer is not an economic operator. The legal manufacturer is the party that places the device on the market. The responsibilities of a manufacturer's subcontractor should be defined in a quality agreement or other legal agreement. It is the responsibility of the legal manufacturer to identify the economic operator role, when applicable.

Q: Are all economic operators required to be MDR certified?

A: There is no "MDR certification" process for economic operators. The economic operator can be audited by the NB as a critical supplier or can be part of an unannounced inspection by the Competent Authority. Having a certified quality system adds a layer of control if/when a NB performs an audit. Note that all critical sub suppliers, not just economic operators, are in scope for NB visits when the legal manufacturer is ISO 13485 certified.

Q: If you distribute third party implants, should the distributor check that the SSCP is on EUDAMED or is that the manufacturer's responsibility?

A: The manufacturer and NB are responsible for entering the SSCP in EUDAMED. The distributor is not responsible per the regulation.

Q: If the importer is part of the parent company (manufacturer) – does the importer need to do separate record keeping for complaints, recall, etc. or is it sufficient for the manufacturer to have a centralized system and the importer can have access to it?

A: The manufacturer can choose to have the importer use the same system for records. This is possible when the importer and manufacturer are part of the same parent organization or if a company can grant guest access to an outside organization. The requirement is that the records are accessible - the location is not prescribed.

Q: If I am a manufacturer and I also sell the medical devices I manufacture, do I have to register both as manufacturer AND as distributor (for economic operators in EUDAMED) or does a manufacturer registration suffice?

A: The manufacturer and distributor regulatory roles apply to all manufacturers. The manufacturer will need to meet the regulatory requirements for both functions. That being said, you may leverage common systems. A single registration number (SRN) is required for all manufacturers but not for distributors, so you will not need to register as a distributor.

Q: Should the distributor be located within one of the member states of the European Union? Can the distributor be located outside the EU, and still distribute in EU?

A: The distributor makes devices available after the importer places the devices in the market. The physical location of the distributor for EU product must be in the EU.

Q: Should an authorized representative have a quality management system?

A: A quality management system is best practice for an authorized representative. The EU MDR does not mandate any certified quality system.See the Slides and Recording ➞

Need additional assistance? Say hello to your expert EU MDR implementers. Our team is ready to help with validated process, procedures, and tools. Click here to learn more about our EU MDR services.

Sources:
[1] Office Journal of the European Union. European Commission. Commission Notice: The ‘Blue Guide’ on the implementation of EU products rules 2016. Published 26 July 2016. Accessed 26 August 2020. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC0726(02)&from=BG
[2] ISO. ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes. Published March 2016. Accessed 26 August 2020. https://www.iso.org/standard/59752.html

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