Important information on the need for an Authorised Representative for spare parts.
Do manufacturers of spare parts for the repair of medical devices also have to have an Authorised Representative in accordance with MDR (EU-REP) or MePV (CH-REP)?
Manufacturers of medical devices based outside the EU or Switzerland usually have to appoint an authorised representative (EU-REP) according to the Medical Device Regulation (MDR) in the EU or a MePV (Medical Device Regulation) representative (CH-REP) in Switzerland when they launch their products on the respective market.
Does this also apply to spare parts that have a different manufacturer's name but are needed to repair my medical device?
According to the MDR , manufacturers of medical devices based outside the EU who wish to distribute medical devices or their components in the EU are obliged to appoint an authorised representative within the EU.
This also applies to components that are sold individually if they can be regarded as medical devices.
A similar regulation applies in Switzerland under the MePV. Here too, foreign manufacturers must appoint a representative in Switzerland in order to legally distribute their products.
It is important to check the specific requirements and definitions in the respective regulatory framework, as there may be differences.
But what about spare parts that are neither classifiable as medical devices nor are they medical devices in the narrower sense?
The question here is focussed on the spare parts required to repair products, i.e. from screws to arm pads. It is important to ensure that the medical device is not significantly altered by the replacement part.
An EU-REP/CH-REP is only necessary if the products are Medical Devices .
«Parts and components» (see Art. 12 para. 1 MedDO, Art. 23 para. 1 MDR) do not correspond to a medical device (see definition Art. 1 and 3, Art. 2 MDR as well as Art. 12 para. 2 MedDO, Art. 23 para. 2 MDR); an EU-REP/CH-REP is not required for “parts and components” that do not have a significant modifying influence on the medical device.
We have been asked this question many times as part of our CH-REP and EU-REP service. Of course, we take a closer look at the components to ensure that the ‘component rule’ is not inadvertently interpreted differently and leads to regulatory problems. Please do not hesitate to contact us. We help you to clarify the regulatory requirements.
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