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) provides expert regulatory consultancy for medical devices and IVDs, ensuring compliance and market access in the UK and internationally. They act as the UK Responsible Person for manufacturers based outside the United Kingdom.
**Expertise & scope**
* Expert regulatory consultancy for Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD).
* Services include CE marking support, Italian and European ministerial registrations, and international registrations outside the EU.
* Specializes in the UK Responsible Person role, which involves registering Medical Devices with the MHRA before market placement.
* Offers Local Representative and License Holder services for accessing foreign markets.
**Reputation / proof points**
* Operates an office in the United Kingdom to fulfill the UK Responsible Person role.
* Provides strategic regulatory consulting to help clients achieve sales goals in national and international markets.
Thema Med (UK Responsible Person) provides expert regulatory consultancy for medical devices and IVDs, ensuring compliance and market access in the UK and internationally. They act as the UK Responsible Person for manufacturers based outside the United Kingdom.
**Expertise & scope**
* Expert regulatory consultancy for Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD).
* Services include CE marking support, Italian and European ministerial registrations, and international registrations outside the EU.
* Specializes in the UK Responsible Person role, which involves registering Medical Devices with the MHRA before market placement.
* Offers Local Representative and License Holder services for accessing foreign markets.
**Reputation / proof points**
* Operates an office in the United Kingdom to fulfill the UK Responsible Person role.
* Provides strategic regulatory consulting to help clients achieve sales goals in national and international markets.
Additional information
Thema Med's UK Responsible Person service is a direct response to regulatory changes following Brexit, requiring manufacturers outside the UK to appoint a local representative. This entity performs specific tasks, such as registering medical devices with the MHRA. The company also offers broader services like CE marking support and international registrations, positioning them as a comprehensive partner for global market access in the medical device sector. Their approach emphasizes ensuring full control of registrations, making manufacturers independent of distributors.
Key Highlights
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Thema Med acts as the UK Responsible Person, a role established by the MHRA for manufacturers outside the UK.
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 comprehensive regulatory consultancy for Medical Devices and IVDs, covering CE marking and international registrations.
Source
“THEMA offers strategic regulatory consulting services to companies producing or distributing Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) on national and international markets.”
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Provides Local Representative and License Holder services to facilitate access to foreign markets.
Source
“In order to access to foreign markets of Medical Devices, it is often necessary to designate a Local Representative: local authorised representative responsible for registration and relations with the Regulatory Authorities of the reference Country and for post-market activities.”
Certifications & Trust Signals
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The company has established an office in the United Kingdom to serve as the UK Responsible Person.
Source
“This entity has its registered 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 regulatory consultancy for medical devices and IVDs.
- Businesses aiming for market access in the UK and internationally.
How engagement typically works
- Provides expert regulatory consultancy.
- Acts on behalf of manufacturers for specific regulatory tasks.
- Offers support throughout the registration process.
Typical deliverables
- UK Responsible Person services (device registration with MHRA).
- CE marking support.
- International market access strategies.
- Local Representative and License Holder services.
Good to know
- Best when a dedicated UK Responsible Person is required due to post-Brexit regulations.
- Suitable for manufacturers of Medical Devices and IVDs.
Pricing
Model:
Custom pricing
HQ:
Imola, IT
Languages:
English
Timezones:
Europe/London
Claim 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
Onboarding Steps
Requires appointment of a UK Responsible Person for manufacturers outside the UK to register devices with the MHRA.
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