UK bodies importing medical devices into the UK from outside of the EU become legally responsible under the medical devices directive for those devices.

Class IIa, IIb or III devices

There are 2 options:

1) Become the Authorised Representative designated by the manufacturer selling under his name; the manufacturer’s Notified Body will audit your facility, or

2) If the manufacturer already has an office or an Authorised Representative in the EU, become an ‘own brander’ selling under your own name and having an agreement with the manufacturer whereby he guarantees that he will supply on demand all the technical documentation associated with the CE marking including changes made since the original approval. You will need to engage a Notified Body to authorise the CE mark under your name; this will probably be the same as the manufacturer’s Notified Body.

An exception to this if you assemble a procedure pack comprising CE marked products. In this case you only have to make a declaration that you:

a) have verified the, mutual compatibility of the devices in accordance with the manufacturers' instructions and have carried out his operations in accordance with these instructions; and

b) have packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and

c) the whole activity is subjected to appropriate methods of internal control and inspection.

Class I devices

If the products are Class I devices, it is likely that no third party has been involved in the approval process. Therefore, as the legally responsible person in the UK, you will necessarily need reassurance that the product meets the essential requirements of the directive. You must have access to the technical documentation associated with the CE marking.

In all cases you must have procedures in place:

1) to ensure the continuing compliance with the essential requirements of the directive during transport and storage of the products under your control

2) review the experience gained from devices in the post production phase, and to implement corrective actions where necessary.

3) to notify the MHRA of relevant adverse incidents.

In all the above cases you must register with the MHRA as either an Authorised Representative or an own brander.

Conformance’s Services

• We can liaise with UK based bodies with a view to becoming your Authorised Representative.

• We can advise you on your responsibilities regarding becoming an ‘own brander’.

• We can advise you of your administrative responsibilities.

• And we can assess products and associated technical documentation with regard to validity of the CE mark and compliance with the essential requirements of the directive.