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**
* Facilitates the registration of Medical Devices with the MHRA for placement on the British market.
* Offers strategic regulatory consulting for medical devices and IVDs.
* Provides support for CE marking for Medical Devices and IVDs under MDR (EU) 2017/745 and IVDR (EU) 2017/746.
* Assists with Italian and European ministerial registrations.
* Manages international registrations outside the EU.
* Offers Local Representative and License Holder services for foreign market access.
* Provides Quality and international GMPs support.
* Conducts training and events related to regulatory affairs.
**Reputation / proof points**
* The company's stated capital is €50,000.
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**
* Facilitates the registration of Medical Devices with the MHRA for placement on the British market.
* Offers strategic regulatory consulting for medical devices and IVDs.
* Provides support for CE marking for Medical Devices and IVDs under MDR (EU) 2017/745 and IVDR (EU) 2017/746.
* Assists with Italian and European ministerial registrations.
* Manages international registrations outside the EU.
* Offers Local Representative and License Holder services for foreign market access.
* Provides Quality and international GMPs support.
* Conducts training and events related to regulatory affairs.
**Reputation / proof points**
* The company's stated capital is €50,000.
Additional information
Thema Med's UK Responsible Person service is specifically designed to address the regulatory requirements following Brexit, where manufacturers outside the UK need a local entity to register their devices with the MHRA. This service ensures that devices can continue to be placed on the UK market by fulfilling the designated role of the UK Responsible Person. They emphasize their role in performing specific tasks on behalf of the manufacturer, including the crucial step of regulatory authority registration before market entry.
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 support for CE marking for Medical Devices and IVDs under MDR and IVDR.
Source
“Thema experts accompany and support Manufacturers in the process of obtaining the CE marking for Medical Devices, IVD products (Rif. MDR (EU) 2017/745) and IVD (Rif. IVDR (EU) 2017/746).”
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Provides services for international registrations outside the EU, facilitating global market access.
Source
“INTERNATIONAL REGISTRATIONS OUTSIDE THE EU”
Certifications & Trust Signals
-
The company's stated capital is €50,000.
Source
“Cap. Soc.€ 50.000 i.v.”
Buyer Snapshot
Best for
- Manufacturers based outside the UK seeking to place medical devices on the British market.
- Companies requiring a designated UK Responsible Person for regulatory compliance.
- Firms needing support with medical device registration and market access in the UK.
How engagement typically works
- Acts on behalf of the manufacturer for specific regulatory tasks.
- Provides expert consultancy and support throughout the registration process.
- Offers a comprehensive range of regulatory services beyond UK RP.
Typical deliverables
- MHRA registration of medical devices.
- Designation as UK Responsible Person.
- Regulatory strategy and compliance advice.
- Support for CE marking and international registrations.
Good to know
- Best when a dedicated UK Responsible Person is required for market entry.
Pricing
Model:
Custom pricing
HQ:
Imola, IT
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
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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
Implied by acting as UK RP and post-market activities
Post Market Support
Yes
UK Entity Country
United Kingdom (general)
Onboarding Steps
Requires appointment of a UK Responsible Person for manufacturers outside the UK to register devices with the MHRA.
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