UKRP
UKRP - Medical Devices
UKRP - Medical Devices
Responsible person in the UK
Post-Brexit, from 1 January 2021, the United Kingdom (UK) has moved to a new medical device regulatory system,
independent of the European Economic Area (EEA).
One of the requirements
that will apply immediately, from 1 January 2021, for all non-UK manufacturers, is that a UK-based UK Responsible Person (UKRP) must be designated.
UKRP for Medical Devices Responsibilities
UKRP for Medical Devices Responsibilities
The obligations of the UK Responsible Person for Medical Devices
are set out in the UK MDR 2002 (as they exist from January 1, 2021). In addition to the registration requirements, the UK Responsible Person (UKRP) must:
- ensure that an appropriate conformity assessment procedure has been carried out by the manufacturer; (if applicable)
- keep a copy of the technical documentation and a copy of the declaration of conformity available;
- keep a copy of the relevant certificate, including any amendments and supplements available for inspection by the MHRA. (if applicable)
In the event of contact by MHRA, UKRP shall:
- provide the requesting entity with all information and documentation necessary to demonstrate compliance of a device;
- if it has samples or access to devices, comply with any request by the entity to provide or access samples and devices;
- if it has neither samples nor access to the device, notify the manufacturer of the entity's requests and respond to MHRA if the manufacturer intends to comply with such request;
- cooperate with MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by the devices.
In the event of a complaint or report,
it is the precise responsibility of UKRP to do the following:
- immediately inform the manufacturer of such reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
- if the manufacturer acts contrary to its obligations under the applicable regulation, terminate the legal relationship with the manufacturer and inform the MHRA and, if applicable, the relevant notified body of such termination.
Specialized UKRP for Medical Devices
Specialized UKRP for Medical Devices
Why use a specialized UKRP
instead of a distributor?
Using a distributor may seem like the easiest option, but it may not be the right one.
With a specialist UKRP you can retain control over how your products are marketed in the UK.
Our UKRP services for Medical Devices
Our UKRP services for Medical Devices
With the role of UKRP for companies, Mdq services offers the following services:
- assistance in understanding and complying with European and UK medical device requirements, including data entry into MHRA registry;
- Identification of national language requirements;
- Identification of national medical device registration requirements and, where permitted, completion of the registration process;
- registration of UKRP client devices on the MHRA register;
- contact with Notified Bodies to perform activities related to the UKCA Marking process;
- serving as official contact with UK authorities;
- receiving and relaying information on adverse events and corrective actions for field safety by notifying applicable national competent authorities;
- maintain access to technical documentation within the UK;
- maintain access to clinical evaluation reports within the UK;
- maintain access to certificates, etc. within the UK.
Mdq Services will be tailored to the needs of the client.
MDQ's services as UKRP are set up:
MDQ's services as UKRP are set up:
Custom made
Custom made
The role of UKRP needs an annual fee
for the responsabilities
of the role. The fee is set up on the company dimension and number of product families.
Every activity is then explained in an accurate price quotation.
Performance
Performance
Post market analysis and reporting. The importance of monitoring perfomance is recognised, we know where to find the information.
Compliant
Compliant
One of our qualified Engineer will take care of the conformity of your products. Devices conformity will adequately check in accordance with the UK requirements.
Small package
Small package
Designed specifically for micro entrprises*: i t contains the annual fee and the basic activities designed for small business.
Medium package
Medium package
Designed specifically for small companies*: it contains the annual fee and the basic activities designed for medium business.
Large package
Large package
Designed specifically for large companies*: it contains the annual fee and the basic activities designed for big companies
*in accordance with Commission Recommendation 2003/361/EC.
Looking for a UKRP for Medical Devices?
We’re here to help!
Looking for a UKRP for Medical Devices?
We’re here to help!
We want to know your needs exactly so that we can provide the perfect solution. Let us know what you want and we’ll do our best to help.