Who? What? Why? How?
About Importer Services
EU MDR/IVDR Importer
Does a Manufacturer have to appoint a MDR Importer at the Date of Application (May 26, 2021) for legacy devices?
Does MedEnvoy have to confirm PRIOR to shipping devices?
We have a reputable European Authorized Representative. Do you really need to also review our Technical Documentation?
Does the EU Importer cover shipments to the UK now that they have left the EU?
No. The UK is no longer part of the European Union and starting January 1, 2021 they will no longer follow European law. You can find additional information on UK requirements here.
We are based in the UK. Do we need an EU Importer?
Yes. The UK is no longer part of the European Union and starting January 1, 2021 they are viewed as a third country and therefore are required to have an European Authoirsed Representative and Importer.
In the case an EU entity of the Legal Manufacturer will be the Importer, where will audits/inspections be held?
Authorities may want to inspect Economic Operators in the EU to verify that these operate according to MDR/IVDR. These inspections will take place at the registered place of the Importer. If the EU entity of the Legal Manufacturer will be the Importer, the address of that entity will be the location that will be inspected.
Who is the Importer / Distributor when a US company ships directly to a hospital in an EU country?
Nobody. Although it is possible this could create issues down the road. The Legal Manufacturer must be sure that devices are not sold onwards by the end user in the EU. Also, EUDAMED will show which Legal Manufacturers operate on the Union market without listed Importers. This might raise questions and create attention for those Legal Manufacturers from Competent Authorities.
What is your involvement in tracking and reporting complaints?
Fully involved! MedEnvoy would gather information from the moment you ship your devices to the EU up to the moment these are delivered to your customer. This could be your distributor or and end user like a clinic, but even a consumer. Whenever we receive a complaint, we will report this to you in a timely mannerr.
Where do we need to identify the Importer on our devices?
Does MedEnvoy need to be ISO13485 certified?
No, there is a requirement to have a QMS, not ISO13485. MedEnvoy however is in the process of implementing an ISO 13485 QMS. We may be perceived as a critical supplier to our clients and therefore our ISO certification will make us an appealing provider of the Importer service. We anticipate to be ISO 13485 certified in 2021.
We market software. Do we need an Importer and/or Distributor under MDR?
This depends on the business model you have in place/in mind. Please be aware that if you don't appoint those Operators, this could possibly create issues down the road. The Legal Manufacturer must be sure that devices are not sold onwards by the end user in the European Union (EU). Also, EUDAMED will show which Legal Manufacturers operate on the EU market without listed Importers and/or Distributors. This might raise questions and create attention for those Legal Manufacturers from Competent Authorities.
In the case an EU entity of the Legal Manufacturer will be the Importer, can MedEnvoy support that entity?
MedEnvoy provides a dedicated Importer Back Office Service that ensures that the EU entity of the Legal Manufacturer operating as Importer will be compliant. If inspections take place these will be held at the registered place of the Importer. If the EU entity of the Legal Manufacturer will be the Importer, the address of that entity will be the location that will be inspected. MedEnvoy may be asked to be on site during those inspections.
When will MedEnvoy get involved with EUDAMED?
We may have situation where EUDAMED is available, but not yet applicable. Manufacturers may need some time to get this setup properly. MedEnvoy would register whenever possible, even under with voluntary registration.
Will the UK MHRA be registered in EUDAMED?
No. The UK Competent Authority is no longer part of the European Union and therefore will not be registered in EUDAMED after December 31, 2020. The same applies the Swiss Competent Authority.
What is a Single Registration Number (SRN)?
This is very important. It is the number by which your company will be identified in the EUDAMED database and all official regulatory documents. It is generated through the EUDAMED system. Distributors do not get SRNs however.
Can we appoint more than one EU Importer?
Yes. There is no limit on the number of EU importers a manufacturer may appoint. However at this time this can only be done at the company level and not for specific product families. EUDAMED will show all importers linked to a manufacturer. This article provides a greta overview on this topic.
For which countries does the role of EU Importer apply?
The role of Importer applies to the entire “Union”; the 27 Member States of European Union (EU) plus Norway, Iceland and Lichtenstein.
Due to Brexit the United Kingdom is no longer part of the EU.
Switzerland and Turkey have agreements in place under the MDD/AIMDD with the EU.
The UK, Switzerland and Turkey have currently (December 2020) no mutual recognition agreements in place with regards to the MDR/IVDR. Legal Manufacturers from these (and of course other Third Countries) are therefore required to appoint an Authorised Representative and Importer established within one of the EU 27 Member States.
Since Norway, Iceland and Lichtenstein are part of EFTA they don’t need a mutual recognition agreement.