If you have been selling your medical devices or IVDs in Europe for some time, you’re probably aware of the requirements for identifying your EU Authorized Representative in labeling. But are you aware of the new requirements for identifying your EU importer? How about your UK Responsible Person or your Swiss Authorized Representative? Don’t worry, many people are perplexed by what is required and what is acceptable. Let’s take a look.
What exactly does medical device “labeling” include?
The term “labeling” in the MDR confuses many who assume it means a physical label attached to the device itself. In reality, Article 2(13) of the European Medical Device Regulation (EUMDR) clarifies that label means the “written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.” The UK and Switzerland have similar interpretations.
* The EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) requires importers to be identified on all medical devices placed on the European market, even if they are “legacy” devices in compliance with the old Medical Devices Directive (93/42/EEC). See this blog article.
** The MHRA has indicated that the importer name does not need to appear on labeling unless the importer also acts as the UK Responsible Person for purposes of UKCA Marking.
*** The UK Responsible Person needs to be identified on product labeling, packaging or the IFU starting 1 July 2023 when the new UKCA Marking will be required in addition to, or replacing, EU CE Marking. See this MHRA information.
**** Swissmedic has indicated that Class I products compliant with the EU MDR may indicate their CH-REP on the packing slip until 31 July 2023. After that date, the CH REP must be indicated on the product or packaging.
NOTE: On 4 January 2022 the EU recognized the EN ISO 15223-1:2021 standard which includes the Importer symbol shown in the table above. This means is it harmonized with the MDR and IVDR. The UK and Switzerland allow the symbol to be used but it must be defined and translated elsewhere in labeling such as your IFU.
Confusion about EU labeling requirements for medical device importers
MDR article 13(3) states: “Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trademark, their registered place of business and the address at which they can be contacted, so that their location can be established.”
Many manufacturers choose a liberal interpretation of “a document accompanying the device” to mean that they can simply identify the EU importer on a packing slip, Declaration of Conformity or on an insert placed inside a shipping box containing multiple devices. This is not acceptable in the EU (see table below). The importer must be clearly identified all the way until the device is “put into service” with the end user. Unless you can prove that a packing slip, DOC or insert contained inside a multipack shipment will make it all the way to the end user, you are not following EU law. Also, in case you were wondering, if you ship devices to a distributor, they do not officially put devices “into service” according to Article 2(34). For a deeper dive on this see MDR Articles 2(27-28) and MDCG 2021-27.
Labeling rules for legacy medical devices
Many medical device companies with unexpired CE certificates issued in compliance with the Medical Devices Directive (MDD 93/42/EEC) erroneously assume they do not need to designate an EU importer. Not true. Article 120(3) of the MDR and MDCG 2025-25 clearly indicate that even though manufacturers may be maximizing the validity of their MDD certificate, certain aspects of the MDR still apply, including Article 13 (importer requirements) of the MDR and IVDR. We go deep on this topic here.
By the way, the importer is not required to be identified until the first time the device is made available on the market. Therefore, it is not required to identify the importer until after the product clears Customs in an EU Member State, Switzerland or the United Kingdom.
While Europe was a single market pre-2020, it is now three markets (EU, UK and Switzerland) and you need to make sure your labeling reflects this new reality. Your safest bet is to add importer information to your product or IFU wherever possible. At MedEnvoy, we can certainly address your questions about importer labeling in any of these three markets so do not hesitate to contact us.