Global Regulatory Services

Following Brexit, the regulatory landscape for medical device companies selling in the United Kingdom has undergone significant changes. Manufacturers outside the UK must appoint a UK Responsible Person (UKRP) to place devices on the Great Britain market (England, Wales, and Scotland).

Role and Responsibilities of the UK Responsible Person

The UK Responsible Person acts on behalf of the non-UK manufacturer to ensure compliance with the relevant regulations. Key responsibilities include:

• Ensuring the declaration of conformity and technical documentation is prepared, and appropriate conformity assessments have been carried out.
• Keeping copies of the technical documentation, declaration of conformity, and relevant certificates for inspection by the MHRA.
• Providing the MHRA with necessary information and documentation to demonstrate device conformity upon request.
• Supplying samples or access to the device if requested by the MHRA.
• Communicate any MHRA requests to the manufacturer and ensure compliance.
• Cooperating with the MHRA on preventive or corrective actions to mitigate risks posed by devices.
• Informing the manufacturer of complaints and reports from healthcare professionals, patients, and users about suspected incidents.
• Terminating the relationship with the manufacturer and informing the MHRA if the manufacturer fails to meet regulatory obligations.

The UKRP’s name and address must be included on the product labelling where the UKCA mark is affixed, although this is not necessary for CE-marked devices.

Submitting Devices for Registration

Manufacturers should aim to appoint their UKRP as soon as possible. The UKRP must then register the relevant devices with the MHRA in line with specified grace periods depending on the device risk classification.

How Global Regulatory Services (GRS) Can Help

Global Regulatory Services (GRS) and Med-Di-Dia support your business in meeting these new regulatory requirements. With offices in the UK and Ireland, GRS and Med-Di-Dia can act as your UK Responsible Person (UKRP) and EU Authorised Representative (EU AR), ensuring seamless compliance and continued market access in the UK and the EU, including Northern Ireland.

Our services include:

• Acting as your UKRP and EU AR, ensuring compliance with UK and EU regulations.
• Managing device registrations with the MHRA.
• Liaising with regulatory authorities on your behalf.
• Providing expert guidance on regulatory requirements and updates.
• Ensuring your product labelling meets all requirements.
• and much, much more!

Contact Us

For expert guidance and support with your regulatory needs, contact our experts by visiting https://globalregulatoryservices.com/global-regulatory-services-contact-details or emailing us at grs@globalregulatoryservices.com

By partnering with GRS and Med-Di-Dia, you can confidently navigate the post-Brexit regulatory landscape and continue to successfully bring your medical devices to market.

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Global Regulatory Services (GRS) offers comprehensive Good Distribution Practice (GDP) training courses designed for professionals involved in the pharmaceutical supply chain. These courses aim to enhance understanding of GDP guidelines, ensuring compliance and maintaining the integrity of pharmaceutical products from the manufacturer to the end-user. The courses are available in various formats: In-House, Online, and Hybrid.

Course Offerings

1. Good Distribution Practice – GDP Operations Training

Duration: 1 Day
Certification: Valid for 2 years
Audience: Site Managers, Responsible Persons (RP), Account Managers, Operations and Administrative Staff, Warehouse Managers, and Personnel.

Agenda:

• GDP guideline overview
• GDP regulations and regulators
• Quality Management Systems (QMS) expectations
• Documentation and traceability
• Falsified Medicines Directive
• Critical GDP roles
• Storage and transport, equipment, cold chain
• Outsourcing and agreements, audits, self-inspections
• Controlled drugs
• Inspection deficiencies and how to avoid them

Fees:

• Individual Online (UK): £250
• Individual Online (EU): €270
• In-House Group (UK, max 8 people): £2600
• In-House Group (EU, max 8 people): €2800

2. Good Distribution Practice – Advanced Refresher GDP Course

Duration: 1 Day
Certification: Valid for 2 years
Audience: Same as GDP Operations Training.

Agenda:

• Basic GDP requirements and new legislation
• Overview of regulators
• QMS overview
• Documentation requirements
• Falsified Medicines Directive
• Storage and transport, cold chain, difficult situations
• Controlled drugs

Fees:

• Individual Online (UK): £160
• Individual Online (EU): €180
• In-House Group (UK, max 8 people): £2400
• In-House Group (EU, max 8 people): €2500

3. Good Distribution Practice – Driver GDP Course

Duration: 1 Day
Certification: Valid for 2 years
Audience: Drivers involved in GDP-related activities.

Agenda:

• Role of the regulator and GDP basics
• Drivers’ GDP responsibilities
• Quality Management Systems (QMS)
• Good Documentation Practice
• Vehicle inspection, suitability, security, hygiene
• Quality standards for premises and equipment
• Falsified medicines awareness
• Risks in transportation

Fees:

• Individual Online (UK): £250
• Individual Online (EU): €270

4. Good Distribution Practice – Driver Refresher GDP Course

Duration: 1 Day
Certification: Valid for 2 years
Audience: Drivers involved in GDP-related activities.

Agenda:

• Refresh knowledge of GDP
• Update on regulations
• GDP journey compliance

Fees:

• Individual Online (UK): £230
• Individual Online (EU): €250

Key Benefits

By attending these courses, participants will gain a practical understanding of GDP and will be able to implement the guidelines effectively in their roles. The training covers critical aspects of GDP, including regulatory requirements, quality management, documentation, and handling of pharmaceutical products.

For more information and to book a course, contact Tracey at tracey@globalregulatoryservices.com

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Global Regulatory Services (GRS): Your Trusted UK MHRA Importer for Medical Devices and IVDs

Navigating the complexities of UK regulatory requirements can be challenging, especially post-Brexit. Global Regulatory Services (GRS) simplifies this process for you, ensuring your medical devices and In Vitro Diagnostics (IVDs) comply with UK regulations.

Our Services and Duties as your Regulatory Importer:

• Comprehensive Compliance Management:
• UKCA & CE Mark Verification: We ensure your products display the necessary UKCA mark or CE marking, as applicable.
• Documentation Review: We verify your products' Declaration of Conformity and technical documentation.
• Labelling and UDI Checks: We ensure all labelling, Unique Device Identifiers (UDI), and accompanying information (IFU) meet UK standards.

• Independent Representation:
• Economic Operator Registration: We act as your designated economic operator, registered with the MHRA by your UK Responsible Person.
• Increased Independence: Avoid relying on distributors for compliance, maintaining greater control over your products.

• Robust Regulatory Support:
• Storage & Transportation Verification: We confirm that storage and transportation requirements are met.
• Complaint Management: We maintain a register of complaints in line with UK reporting requirements.
• Risk Management: We promptly inform manufacturers if a device poses serious risks or is non-compliant.

• Seamless Integration with Your Operations:

• Collaboration: We work closely with legal manufacturers and UK-responsible persons to ensure the seamless reporting of serious incidents or risks to the MHRA.
• CAPA Support: We assist with Corrective and Preventive Actions (CAPA) to address any compliance issues.

Why GRS?

1. Expertise: With years of experience as a regulatory importer and responsible person, GRS has the expertise to navigate complex regulatory landscapes.
2. Efficiency: Our streamlined processes ensure quick and seamless compliance, reducing your time to market.
3. Reliability: Trust GRS to manage your regulatory responsibilities with professionalism and precision.

Take the Next Step:

With GRS as your trusted partner, ensure your products meet all UK regulatory requirements. Contact us today to learn more about our comprehensive Regulatory Importer services.

Contact Us

Email- grs@globalregulatoryservices.com 

Web Form- https://globalregulatoryservices.com/global-regulatory-services-contact-details

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The Life Science Industry is the most regulated industry.  Medicines used to treat chronic diseases to the common cold would not be available to patients without the teams of specialists (including regulatory affairs professionals) who work to ensure that these medicines gain approval from the relevant Health Authorities, such as the MHRA and the US Food & Drug Administration (FDA).

A good regulatory affairs professional will maintain their awareness of changes in regulations which can affect clinical trials and regulatory strategy etc.  In addition, new areas of regulation appear because of technological advances and so they have to continually learn and gain experience in these new emerging fields.  They are often key to deciding the best regulatory route to take in order to be successful in obtaining a product licence for the company they are representing and to stay ahead of the competition.  An ever increasing number of regulatory affairs professionals include highly trained scientists and medical professionals who are able to influence the overall drug development process.

GRS has a global team of regulatory affairs specialists who ensure their skills are kept up-to-date.  We can advise on regulatory development projects and overall strategy (including an evaluation of the available regulatory procedures) in order to determine the best possible outcome for our clients both strategically and commercially.

Please contact us with your specific regulatory compliance requirements.

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