Thema Med (UK Responsible Person)
Thema srl
Thema Med is a UK Responsible Person service provider, offering expert regulatory consultancy for medical devices and IVDs. They ensure compliance and market access in the UK and internationally.
Thema Med specializes in providing UK Responsible Person (UK RP) services, ensuring that medical devices and In Vitro Diagnostic (IVD) devices comply with UK regulations for market access. As a leading medical regulatory consultancy, Thema Med offers strategic regulatory consulting to manufacturers and distributors, guiding them through complex changes and necessary transformations to operate successfully in the medical device field. Their services extend beyond the UK, encompassing support for CE marking, Italian and European ministerial registrations, and international registrations outside the EU. Thema Med also provides expertise in Quality and international GMPs, training, and events. They are dedicated to helping clients achieve their sales objectives through reliable and competent regulatory partnerships, ensuring products are safe, effective, and compliant. With a mission to save lives and preserve health, Thema Med aims to be a key part of a system focused on disseminating information and training in the medical field. They strive to enable global access to adequate treatments and products, making a significant and lasting impact in their operational sectors. Their experienced staff collaborates with clients, learners, and beneficiaries to find the best solutions and protect interests.
About
**Who they are**
Thema Med (UK Responsible Person) is a regulatory consultancy specializing in medical devices and IVDs, offering services to ensure market access in the UK and internationally. They act on behalf of manufacturers to perform specific regulatory tasks.
**Expertise & scope**
* Expert regulatory consultancy for Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD).
* Services include strategic regulatory consulting, CE marking support, Italian and European ministerial registrations, and international registrations outside the EU.
* Provides UK Responsible Person (UK RP) services, including registration of Medical Devices with the MHRA for manufacturers based outside the United Kingdom.
* Offers Local Representative and License Holder services for accessing foreign markets.
* Ensures compliance with UK regulations following Brexit.
**Reputation / proof points**
* Operates an office in the United Kingdom to act on behalf of manufacturers.
* Provides services for international registrations outside the EU.
Thema Med (UK Responsible Person) is a regulatory consultancy specializing in medical devices and IVDs, offering services to ensure market access in the UK and internationally. They act on behalf of manufacturers to perform specific regulatory tasks.
**Expertise & scope**
* Expert regulatory consultancy for Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD).
* Services include strategic regulatory consulting, CE marking support, Italian and European ministerial registrations, and international registrations outside the EU.
* Provides UK Responsible Person (UK RP) services, including registration of Medical Devices with the MHRA for manufacturers based outside the United Kingdom.
* Offers Local Representative and License Holder services for accessing foreign markets.
* Ensures compliance with UK regulations following Brexit.
**Reputation / proof points**
* Operates an office in the United Kingdom to act on behalf of manufacturers.
* Provides services for international registrations outside the EU.
Additional information
Thema Med's UK Responsible Person service is specifically designed to address the regulatory requirements introduced after Brexit, necessitating a representative on UK territory for manufacturers based outside the United Kingdom. This service facilitates the registration of medical devices with the MHRA, ensuring compliance for market entry. They also offer broader international regulatory support, including CE marking and registrations in European and non-European markets, positioning them as a comprehensive partner for global medical device commercialization.
Key Highlights
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Provides UK Responsible Person (UK RP) services for manufacturers outside the United Kingdom.
Source
“MGRA created a new role in the regulation of Medical Devices and IVD, known as UK Responsible Person. This entity has its registered office in the United Kingdom and it acts on behalf of the Manufacturer to perform specific tasks, such as the registration of Medical Devices at the Regulatory Authority before they are placed on the British market.”
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Offers expert regulatory consultancy for Medical Devices and IVDs, ensuring compliance and market access.
Source
“Thema Med is a UK Responsible Person service provider, offering expert regulatory consultancy for medical devices and IVDs. They ensure compliance and market access in the UK and internationally.”
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Facilitates CE marking and international registrations outside the EU.
Source
“ServicesStrategic regulatory consultingCE marking supportItalian and european ministerial registrationsInternational registrations outside the EU”
Certifications & Trust Signals
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Established presence in the UK for regulatory representation.
Source
“office in the United Kingdom and it acts on behalf of the Manufacturer to perform specific tasks”
Buyer Snapshot
Best for
- Manufacturers based outside the UK needing a UK Responsible Person.
- Companies seeking to register medical devices and IVDs in the UK.
- Businesses requiring support for CE marking and international market access.
How engagement typically works
- Provides direct representation for regulatory authorities.
- Offers end-to-end regulatory consulting and support.
- Acts as a reliable and competent partner in the regulatory field.
Typical deliverables
- UK Responsible Person registration services.
- MHRA registration for medical devices.
- CE marking support documentation.
- International registration filings.
- Strategic regulatory advice.
Good to know
- Best when seeking a dedicated UK RP for market entry post-Brexit.
- Suitable for companies needing to navigate complex international medical device regulations.
Pricing
Model:
Custom pricing
HQ:
Imola, IT
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Custom pricing
Starting from:
EUR 3,500
Included services:
UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB:
Yes
Supports NI:
Yes
MHRA Support:
Yes
Can Be Named On Label:
Yes
Vigilance Support:
Yes
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
MHRA Portal Support:
Yes
Additional uk_rp Details
Device Classes Supported
All device classes (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England (implied by MHRA)
Onboarding Steps
Requires appointment of a UK Responsible Person for manufacturers outside the UK to register devices with the MHRA.
