#ukrp

[cert3global]

Understanding the Role of the UK Responsible Person: Your Key to Compliance

One of the most significant consequences of Brexit for businesses placing products on the UK market is the emergence of the UK Responsible Person (UKRP). Similar to the European Authorized Representative (EAR) under the EU legislation, a UKRP acts as the point of contact for regulatory authorities and consumers. They ensure compliance with UK laws and regulations, taking on responsibilities formerly carried out by the EAR.

[ddregpharma]

Overview of The United Kingdom Responsible Person (UK RP)

A UK RP is a person who is responsible for the financial and regulatory compliance of a non-UK company that operates in the UK. The UK RP must be a resident of the UK and must have the necessary knowledge and experience to fulfil this role. The UK RP can help to ensure that the non-UK company complies with all UK laws and regulations and can also help to improve the non-UK company's reputation with the UK authorities.

[ryuchaekkeuhyojeonsaejia]

UKRP CHRISTMAS CONCERT 2023

[omcmedicalblog]

Medical Device Registration in United Kingdom | OMC Medical Limited

Ministry of Health

Department of Health and Social Care (UK)

Regulatory Authority

Medicines & Healthcare products Regulatory Agency (MHRA)

Medical Device Regulation

The Medical Devices Regulations 2002

UK Conformity Assessed Marking Process (effective Jan 2023)

Official Language

English

Classification

Class I, IIa, IIb and III

Registration Process

Determine the device classification

Appoint an Authorized Representative – UK Responsible Person (UKRP)

Until July 2023, the manufacturer will follow a regulatory pathway as per EU MDR 2017/745. The medical device should possess an EU CE Mark and submit Technical File to register with MHRA and market the device in the UK.

After July 2023, the medical device will be subjected to the UK Conformity Assessed (UKCA) marking process to continue marketing the device in the UK (England, Wales and Scotland).

UKCA Mark Assessment Routes

Class I: Product must comply with requirements of UK MDR 2002. The manufacturer prepares a Declaration of Conformity. For Sterility or Metrology Class I devices, an Approved Body (within the UK) must be appointed for conformity assessment.

Class IIa, IIb and III: Appoint an Authorized Body (within the UK) to carry out the conformity assessment. Once approved by Authorized Body, affix the UKCA mark, prepare a Declaration of Conformity and register the product with MHRA. The medical device can now be marketed in the UK (England, Wales and Scotland)

Documents Required

Declaration of Conformity (DoC)

Product Description

Technical File

Label, IFU and User Manual

Letter of Authorization

Clinical Studies Report

CE Mark or UKCA mark

Risk Management Plan

Post-market surveillance

General safety and performance requirements

Product verification and validation

Biocompatibility, Sterilization Information (if applicable)

Post-market Requirements

Serious public health threat – 2 calendar days

Death or unanticipated serious deterioration in state of health – 10 calendar days

Others – 30 calendar days

Guidance for manufacturers on vigilance

Applicable QMS

Essential Principles Requirements – Annex I, The Medical Device Regulations 2002

ISO 13485

Registration Timeline

2-4 weeks

Authorized Representative

Yes. UK Responsible Person (UKRP)

License Validity

License expires with the CE mark or UKCA mark expiry.

Special Notes

Distributors and Suppliers are not required to register with MHRA

Originally Published at: https://omcmedical.com/medical-device-registration-in-united-kingdom/

[inspiringsandhya]

Understanding UKRP: Navigating the Regulatory Landscape for Bringing Your Medical Device to the UK

In today’s rapidly evolving medical device industry, it is crucial for businesses to stay updated with the latest regulations and navigate the regulatory landscape effectively. One key aspect that companies need to comprehend is the UK Responsible Person (UKRP) regulations. This article aims to provide a comprehensive understanding of UKRP and offer guidance on how to navigate the regulatory…

[cert3global]

Streamlining Your Business with Free Sales Certificates and EU CE Marking

MHRA registration is a mandatory requirement for all medical device companies operating in the UK. By registering your medical device with the MHRA, you are confirming that your product meets the essential safety, performance, and quality requirements specified by the agency. Failure to obtain MHRA approval can result in legal consequences, including fines and restrictions on marketing and sales activities.

[freyrsolutions]

UK Responsible Person (UKRP), UK Responsible Person Medical Devices

[fiorick]

UKRP - RA Consultant

UKRP – RA Consultant

Job title: UKRP – RA Consultant Company: Real Staffing Job description: to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England…. ISO 13485 QMS experience is ideal. Risk management ISO 14971 experience. Experience in dealing with Regulatory bodies… Expected salary: £50000 – 60000 per year Location:…

[ryuchaekkeuhyojeonsaejia]

I just found the perfect outfit for SeuBim's UKRP Christmas Concert Performance 😍😍😍

[omcmedicalblog]

MHRA Guidance on Stand-alone Software Medical Devices

Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices.

In the UK, medical devices are subject to UKCA marking. The UKCA marking is no exception to software medical devices.

Software Medical Devices or not

Classifying software or a mobile app as a medical device can be challenging. If the software or app has a well-defined intended medical purpose, it is essential to mark CE or UKCA on the product.

Intended purpose

A medical device is defined by the intended purpose on the device labelling, Instructions for use and any promotional materials, including brochures.

Depending on the intended purpose, the device can be classified as a device with a medical purpose if it:

Prevents disease

Diagnoses a disease, injury or handicap

Monitoring a disease, injury or handicap

Treats or alleviation of a disease, injury or handicap

Compensates an injury or handicap

Investigates replaces or modifies anatomy or physiological process

Controls conception

A software device is considered to have a medical purpose if it has one of the following features and looks into in vitro data:

Concerning a physiological or pathological state          

Concerning a congenital abnormality

To determine the safety and compatibility with potential recipients

To monitor therapeutic measures

Software Medical device classification and essential requirements

For software medical devices, the following classification rules of Medical Device Directive 93/42/EEC  apply.

Rule 9 includes active therapeutic devices intended to administer or exchange energy

Rule 10 includes active devices intended for the diagnosis

Rule 12 includes all other active class I devices

Rule 14 includes devices used for contraception or the prevention of the transmission of sexually transmitted diseases

One of the essential requirements for software apps is for the benefit to outweigh any risks. Essential requirements also state the risks of ergonomic features and the intended use environment.

Manufacturers of such devices must ensure that the user interface must be consistent, and graphics and text must be clear and legible. The software or app must be designed with safety in mind.

In addition, the clinical evaluation following Annex X of the UK MDR must be done. A similar set of requirements applies to IVDs.

Labelling requirements

The software labelling must be clear and visible to the user. Manufacturers must ensure the app meets relevant requirements and displays UKCA  marking on the landing page itself.

The following particulars must be present on the software label:

App name

Version number

Date of manufacture

Manufacturer name and address

UKRP name and address

Purpose of software

Warnings and precautions

UKCA or CE marking

Examples of Software with a medical purpose

Software with a medical purpose may be devices that:

Provide information for the calculation of drug dose using IVD data such as blood

Enables therapeutic drug monitoring

Monitor blood glucose levels

Provides medical conditions based on input user data

Indicate potential developing disease based on the entered data

Automate the pathway for treatment for an individual

Enables people with visual or hearing disabilities to read or listen by magnifying text or amplifying sounds

Software or app without an intended medical use would include:

General apps for recording patient images which later require the diagnosis of a clinician

Apps that give general recommendations instead of user-specific advise

Software that is intended to record heart rates, such as fitness or sports apps

Apps that remind patients of drug intake

Apps to treat non-medical conditions

Software that provides tips or advice

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Originally Published at: https://omcmedical.com/mhra-guidance-on-stand-alone-software-medical-devices/

[emson9624]

medical device classification uk - We care about our clients; we work with you on your budget to provide a suitable solution for both parties. We pride ourselves in providing service better than industrial standards. https://omcmedical.com/ukca-marking/

[cert3global]

Mastering Post-Market Surveillance: Safeguarding Medical Devices

Post-market surveillance is a systematic approach that helps manufacturers monitor and assess the performance and safety of their medical devices once they are on the market. It involves the collection and analysis of data from various sources, such as user feedback, complaints, adverse events, and clinical studies, to ensure that any potential risks or issues are identified and addressed promptly.

[srgenxx]

Logos hechos a modo de hobby para un sv de Samp (UKRP) + Nueva marca de agua + Banner de la LSPD