In the EU market

Question 1

What’s an EU Authorized Representative?

Answer 1

Is any natural or legal person established within the EU who acts on behalf of a manufacturer located outside the EU. The representative receives and accepts a written mandate from a manufacturer to act on its behalf for specified tasks with regard to the manufacturer’s obligations under

Question 2

EU Authorized Representative:

Answer 2

• Is required when a manufacturer is established outside the EU
• Must ensure that the mandate is accepted in writing
• Must verify Conformité Européene (CE) mark, Declarations of Conformity (DoCs), and technical documentation
• Must ensure that the manufacturer and the Unique Device Identifier (UDI) are registered in European Database of Medical Devices (EUDAMED)
• Must keep a copy of technical documentation, DoC, and Notified Body (NB) certificates (if relevant) to make available to Competent Authorities (CAs)
• Is fully liable (jointly and severally with manufacturer) for consequences of product deficiencies
• Must appoint a person responsible for regulatory compliance

Question 3

Does the “EU Authorized Representative” need to be registered?

Answer 3

Yes. EU Authorized Representatives must register in EUDAMED and get a single registration number (SRN).

Question 4

Are there new economic operators in MDR/IVDR?

Answer 4

Yes. This is the list of all operators: Manufacturer, authorized representative, importer, distributor, assembler or sterilizer of systems/procedure packs.

Question 5

When Economic operators assumes manufacturer responsibilities?

Answer 5

• Makes a device available under his/her own name (Own Brand Labeling)
• Changes the intended purpose of a device already on the market
• Modifies a device already on the market

Question 6

What’s distance sales and how it is affected by EU MDR?

Answer 6

Distance sales refers to medical devices or services delivered via information society services (e.g., online selling).
E.g: When a mammogram is taken in the Netherlands and is interpreted by a radiologist in India (or anywhere outside the EU), the devices used by the radiologist in India for the evaluation must comply with MDR.

Question 7

What are the differences between MDD and MDR w.r.t systems and procedure packs?

Answer 7

• The definition is extended to systems and procedure packs of medical and nonmedical devices.
• MDR includes a definition of “system” as a combination of products, either packaged together or not, which are interconnected or combined, but only when it is done to achieve a specific medical purpose.
• Systems and procedure packs must be assigned a Basic UDI-DI, registered in EUDAMED.

Question 8

How does MDR treats reprocessing of single-use devices and refurbishing?

Answer 8

Legislators, even after long debates, could not agree on a harmonized approach on reprocessing of single-use devices. So, the text in MDR is a compromise.

Question 9

How does MDR treats the device modification on the installed base?

Answer 9

When a modification to a device that is already in service impacts safety or performance, the modified device is considered a new device and must comply with MDR.
If an institution such as a hospital modifies one of its own devices, they must also comply within their role.
Special impact on upgrades: Upgrade packages must be CE marked under MDR.

Question 10

How does MDR treats the refurbishing?

Answer 10

If equipment, CE marked under MDD, is already in the EU and is refurbished within the EU, the equipment can be made available again.

But:
Full refurbishment is considered re-manufacturing. Therefore, the fully refurbished device must comply with the same obligations as a new device.
Since all imported devices must be MDR/IVDR compliant after the date of application, a clear process of temporary exportation must be implemented, if refurbishing activities are performed outside the EU.

Question 11

What’s Post Market Surveillance (PMS) plan?

Answer 11

The PMS plan, created during the product development phase for every device, is executed in the post-market phase.

Question 12

What does the PMS cover?

Answer 12

• Information concerning serious incidents, including information from post-market reports (PSUR and PMS reports), and Field Safety Corrective Actions
• Records referring to non-serious incidents and data on any undesirable side effects
• Information from trend reporting, taking misuse and off-label use into consideration
• Relevant specialist or technical literature, databases, and/or registries
• Information, including feedback and complaints, provided by users, distributors, and importers
• Publicly available information about similar medical devices