Specculo (EU Authorized Representative)
Specculo
Specculo is an EU Authorized Representative (EU AR) service provider, ensuring your products comply with European regulations for market access.
Specculo offers specialized services as an EU Authorized Representative (EU AR), a crucial role for manufacturers seeking to place their products on the European market. By acting as the EU AR, Specculo ensures that your products meet all relevant European Union directives and regulations, facilitating seamless market access. Their expertise helps navigate the complex compliance landscape, providing peace of mind and enabling businesses to focus on innovation and growth within the EU. As a dedicated EU AR, Specculo manages the necessary documentation, liaises with regulatory authorities, and ensures ongoing compliance throughout the product lifecycle. This service is essential for non-EU manufacturers who need a reliable representative within the European Union to handle regulatory responsibilities and demonstrate adherence to safety and quality standards.
About
**Who they are**
Specculo (EU Authorized Representative) is a consulting firm specializing in representation services, regulatory affairs, and quality assurance for medical devices and IVDs in the EU and UK. Founded by Kenneth Shaw, the firm combines deep technical expertise with a hands-on approach to help companies navigate complex regulatory landscapes.
**Expertise & scope**
* Acts as the EU Authorized Representative (EU AR), fulfilling core responsibilities under Article 11 of the MDR and IVDR.
* Verifies technical documentation and ensures ongoing compliance with European regulations.
* Manages Eudamed registrations, including Actor and UDI-DI.
* Provides monthly regulatory support, including one hour of dedicated time with their regulatory team.
* Monitors and communicates EU regulatory changes affecting medical devices and IVDs.
* Assists with market access and ensures products comply with European regulations.
* Offers consulting services for regulatory affairs and quality assurance.
* Specializes in representation services for medical devices and IVDs.
**Reputation / proof points**
* Supports startups and established manufacturers.
* Focuses on ensuring quality, safety, and performance while empowering innovation.
Specculo (EU Authorized Representative) is a consulting firm specializing in representation services, regulatory affairs, and quality assurance for medical devices and IVDs in the EU and UK. Founded by Kenneth Shaw, the firm combines deep technical expertise with a hands-on approach to help companies navigate complex regulatory landscapes.
**Expertise & scope**
* Acts as the EU Authorized Representative (EU AR), fulfilling core responsibilities under Article 11 of the MDR and IVDR.
* Verifies technical documentation and ensures ongoing compliance with European regulations.
* Manages Eudamed registrations, including Actor and UDI-DI.
* Provides monthly regulatory support, including one hour of dedicated time with their regulatory team.
* Monitors and communicates EU regulatory changes affecting medical devices and IVDs.
* Assists with market access and ensures products comply with European regulations.
* Offers consulting services for regulatory affairs and quality assurance.
* Specializes in representation services for medical devices and IVDs.
**Reputation / proof points**
* Supports startups and established manufacturers.
* Focuses on ensuring quality, safety, and performance while empowering innovation.
Additional information
Specculo's EU Authorized Representative service includes verifying technical documentation and ensuring ongoing compliance with MDR and IVDR. They handle Eudamed registrations and provide monthly regulatory support, offering one hour of dedicated consultation time. This support is valuable for navigating complex questions, new product launches, or developing ongoing compliance strategies. They also keep clients informed about EU regulatory changes. Manufacturers must ensure Specculo has continuous access to essential documentation such as the Declaration of Conformity, Technical Documentation, and Notified Body Certificates.
Key Highlights
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Specculo acts as your EU Authorized Representative, fulfilling core responsibilities under Article 11 of the MDR and IVDR.
Source
“As your designated EU Authorized Representative, we fulfill all core responsibilities under Article 11 of the MDR and IVDR.”
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Provides monthly regulatory support, including one hour of dedicated consultation time with their regulatory team.
Source
“Every month, you get one hour of dedicated regulatory support with our regulatory team, perfect for navigating complex questions, new product launches, or ongoing compliance strategy.”
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Handles all necessary Eudamed registrations, including Actor and UDI-DI registrations.
Source
“We handle all necessary Eudamed registrations on your behalf. Whether its Actor or UDI-DI registrations, we’ve got you covered.”
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Specializes in representation services, regulatory affairs, and quality assurance for medical devices and IVDs in the EU and UK.
Source
“Specculo is a consulting firm specialising in representation services, regulatory affairs and quality assurance related to medical devices and IVDs in the EU and UK.”
Certifications & Trust Signals
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Specculo was founded by Kenneth Shaw, who has years of experience in senior roles within global consulting and EU AR firms.
Source
“After years of working in senior roles within global consulting and EU AR firms, Kenneth recognised the need for a consultancy that combined deep technical expertise with a hands-on, partner-driven approach.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking EU market access.
- Companies needing a dedicated EU Authorized Representative.
- Businesses requiring ongoing regulatory support and compliance monitoring.
How engagement typically works
- Partner-driven approach.
- Hands-on support.
- Regular communication and updates.
Typical deliverables
- EU Authorized Representative services.
- Technical documentation verification.
- Eudamed registrations (Actor, UDI-DI).
- Monthly regulatory support sessions.
- Updates on EU regulatory changes.
Good to know
- Best when manufacturers can provide continuous access to required documentation.
- Requires clear agreement on device scope within the mandate.
HQ:
Valletta, DE
Languages:
English, French
Timezones:
Europe/Paris
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
FR, BE, DE, NL, ES
Industries:
Medical devices, IVD, Healthcare
Portfolio:
1-5, 6-25
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 2,200
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
EU Entity Country:
Malta
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, IVD
Post Market Support:
Yes
Labeling Review:
No
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
Additional eu_ar Details
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Malta (implied by +356 phone number and EU AR focus)
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III (implied by MDR/IVDR support)
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Requires an AR mandate agreement. Manufacturer must ensure continuous and permanent access to Declaration of Conformity, Technical Documentation, Notified Body Certificates, QMS procedures, and information on significant changes.
