simul Why do you need a UK Responsible Person in Great Britain?
If you are a manufacturer placing medical devices on the British market but are located outside Great Britain (England, Scotland and Wales), the law requires you to have a UK Responsible Person (UKRP) here.
http://mccallsnurseries.com/623-2/ What is a UK Responsible Person?
The UK Responsible Person acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. The UK Responsible Person must:
- Register the devices of the manufacturer it represents in the database set up by the MHRA.
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer
- Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA
- In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
- Where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device
- Where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
- If the manufacturer acts contrary to its obligations under these Regulations:
- Terminate the legal relationship with the manufacturer; and
- Inform the MHRA and, if applicable, the relevant Approved Body of that termination.
Why should you choose Abnovo Ltd as your UK Responsible Person?
Acting as a UKRP is a very serious responsibility and is best entrusted to somebody who understands the British regulatory requirements and has significant practical experience in dealing with them.
AbNovo’s managing director, Mika Reinikainen, is a lawyer who has over 40 years of experience in medical device regulatory affairs. He is also the founder and Chairman of the UK Responsible Person. His network of partners can provide a multitude of services to a medical device manufacturer such as running clinical trials, developing and implementing quality systems and carrying out all the processes needed to obtain the UKCA mark.
AbNovo’s unique approach of partnership ensures that the manufacturer’s regulatory and business objectives are fully taken into account. We will make a special effort to get to know the manufacturer’s products and key staff. AbNovo’s mission is to minimise regulatory risk to its clients in the marketplace.
What services does AbNovo offer?
The following are the basic UKRP services offered to all Abnovo’s clients:
- An address in England.
- Immediate analysis of any issues arising (suspected adverse incident, compliance query from authorities, etc.)
- Product registration.
- Periodic regulatory health assessments.
- Dealing with the UK Competent Authority (MHRA) and UK Approved Bodies.
These are basic services that will be provided to all clients. AbNovo’s ability to provide further services is very extensive. We therefore initiate our partnership by determining together your needs and putting together a customised package of services that specifically address your needs.
How much is it going to cost you?
The actual fees will depend on the nature and number of the products concerned as well as various risk factors. The fee structure consists of:
–An onetime initiation fee to set up the manufacturer as a client
–An annual retainer fee to cover routine basic activities
–Fees for any additional work done beyond the basic activities (subject to case by case approval by the manufacturer).
Interested in our services? Please contact us.