Trusted In-Country Representative for Medical Devices

Commonly manufacturers may enter their (home) market prior to entering unchartered territories. When entering the market in which the manufacturer is located, a local representative by law is not required. However, when entering a foreign market, manufacturers commonly will need to appoint an In-country representative for medical devices. This can be an Authorised Representative (e.g. in the European Union and Switzerland), a UK Responsible Person (In the UK) and a US Agent and potentially a US Correspondent (in the United States).

The roles and responsibilities of the authorised in-country representatives are different for most regulatory jurisdictions, where in some jurisdictions the representative is severally liable for defective products marketed by the manufacturer whereas in others, the representative only acts as a point of contact to the regulatory authorities.

As MedQAIR is based in the European Union, we can directly act as the EU In-Country Representative for MDR compliance and through our partner and liaison network, we can support in the United States, the United Kingdom and Switzerland.