If you are a manufacturer of a Medical devise outside the EU or UK you are required under the directives to appoint an Authorised Representative. International Associates Limited is able to act as your Authorised Representative in both Europe and also within the UK should there be a no deal Brexit or if the deal doesn’t include some form of mutual recognition between the EU and the UK.
International Associates Limited and its Ireland based subsidiary are able to offer the service of operating as your Representative in both the EU and the UK covering any scenario relating to Brexit.
For medical devices and in vitro diagnostic medical devices (IVDs), after the UK leaves the EU, any UK-based Authorised Representative will no longer be recognised under EU law. This means they will not be recognised as able to carry out tasks on the manufacturer’s behalf for the purposes of placing products on the EU market. In order to place devices on the EU market, manufacturers with an Authorised Representative based in the UK will need to establish a new Authorised Representative in an EU country.
Regulating medical devices in the event of a no deal Brexit
You can read more information on the UK Gov web site here about what is actually required.
However to summarise:-
A new role – the UK Responsible Person – has been created under the UK MDR 2002 (as amended by the UK MDR 2019), which applies from the day the UK leaves the EU. The UK Responsible Person, who must be established in the UK, acts on behalf of a manufacturer established outside the UK to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the device is placed on the UK market
The EU Authorized Representative and UK Responsible Person roles are generally similar and include:
- Verify the Declaration of Conformity
- Review the Technical Documentation
- Check where applicable that an appropriate conformity assessment exist
- Keep the previous documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least 10 years and for implantable devices, it’s 15 years)
- Record Retention and Document control including version controls.
- Ensure Labelling is correct and includes the details of the Authorised Representative.
Verify that the manufacturer is complying with the registration of the Unique Device Identification according to article 27
Make sure that the registration of the device is performed according to article 29, Register on EUDAMED for the EU or MHRA for UK.
Also that the registration of the manufacturer, Authorized Representative and importers are done according to article 31
In case requested by the competent authorities, the Authorized Representative should give all the information and documentation necessary to prove the conformity of a device, in an official language
Keep the manufacturer informed of any request coming from the competent authorities.
Verify that the competent authorities receive the samples or is given access to the device.
Cooperate with the competent authorities for any preventive or corrective action taken to cut or mitigate the risks posed by devices
Vigilance report / monitoring
Immediately tell the manufacturer about complaints and reports from healthcare professionals, patients and users related to suspected incidents performed by their device.
This can be something important to precisely write on the agreement. Check the last chapter on KPIs
Terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation
(Note: the requirements for In-vitro Devices are slightly different.)
Changing your Authorised Representative.
Changing your Authorised Representative is a fairly straightforward process. Article 13 of the Medical Device Regulation 2017/745 gives full details of how this can be done.
First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).
To be compliant, the manufacturer should address the following aspects:
The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.
The date until which the manufacturer can show the outgoing AR on the information or promotional material.
The transfer of documents, including confidentiality aspects and property rights
The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.