MDSS (EC REP)
MDSS GmbH
MDSS is a leading European Authorized Representative (EC REP) with over 30 years of experience, specializing in regulatory affairs for medical and in-vitro diagnostic devices. They offer comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia.
MDSS GmbH, established in the European Union, is a trusted Authorized Representative (EC REP) with over 30 years of experience in providing In-Country Representation and specializing in Regulatory Affairs for Medical and In Vitro Diagnostic Devices. They are recognized as a leading European Authorized Representative, serving clients for over two decades from the same trusted address. MDSS offers comprehensive In-Country Representation services across the EU, United Kingdom, Switzerland, USA, and Australia. They act as European Authorized Representative, UK Responsible Person, Swiss Authorized Representative, and U.S. Agent, allowing non-EU based companies to focus on their core business, including innovation, while ensuring compliance with regional regulations. Specifically for the EU market, MDSS assists with EU Registration with the European Authorities. They are crucial for non-EU based Medical Devices Companies needing to appoint an EU Authorized Representative to place devices on the EU market, as mandated by regulations like MDR (EU) 2017/745 and IVDR (EU) 2017/746. MDSS also provides representation for compliance with the AI ACT and the General Product Safety Regulation (GPSR). Furthermore, MDSS acts as an EU Representative for the General Data Protection Regulation (GDPR) for processors and controllers operating outside the EU who handle personal data of individuals within the EU. They ensure compliance with Article 27 of the GDPR, acting as a point of contact for supervisory authorities and data subjects.
About
**Who they are**
MDSS (EC REP) is a European Authorized Representative with over 30 years of experience, specializing in regulatory affairs for medical and in-vitro diagnostic devices. They offer comprehensive in-country representation services.
**Expertise & scope**
* Serves as the EU Authorized Representative (EC REP) for medical and in-vitro diagnostic device manufacturers located outside Europe.
* Facilitates placing devices on the EU market by fulfilling requirements for CE marking under the MDR (EU) 2017/745 and IVDR (EU) 2017/746.
* Acts as a representative for General Data Protection Regulation (GDPR) compliance for organizations outside the EU handling personal data of EU residents.
* Provides representation services across the EU, UK, Switzerland, USA, and Australia.
**Reputation / proof points**
* Over 30 years of experience in regulatory affairs for medical and in-vitro diagnostic devices.
MDSS (EC REP) is a European Authorized Representative with over 30 years of experience, specializing in regulatory affairs for medical and in-vitro diagnostic devices. They offer comprehensive in-country representation services.
**Expertise & scope**
* Serves as the EU Authorized Representative (EC REP) for medical and in-vitro diagnostic device manufacturers located outside Europe.
* Facilitates placing devices on the EU market by fulfilling requirements for CE marking under the MDR (EU) 2017/745 and IVDR (EU) 2017/746.
* Acts as a representative for General Data Protection Regulation (GDPR) compliance for organizations outside the EU handling personal data of EU residents.
* Provides representation services across the EU, UK, Switzerland, USA, and Australia.
**Reputation / proof points**
* Over 30 years of experience in regulatory affairs for medical and in-vitro diagnostic devices.
Additional information
MDSS (EC REP) supports manufacturers in navigating complex EU regulations, including the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). They act as the mandated point of contact for authorities and data subjects regarding device compliance and data protection. Their services are crucial for non-EU established manufacturers seeking to access the European market, ensuring adherence to essential regulatory mandates for CE marking. They also offer GDPR representation for entities processing EU resident data.
Key Highlights
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Over 30 years of experience as a European Authorized Representative (EC REP).
Source
“MDSS is a leading European Authorized Representative (EC REP) with over 30 years of experience”
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Specializes in regulatory affairs for medical and in-vitro diagnostic devices.
Source
“specializing in regulatory affairs for medical and in-vitro diagnostic devices.”
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Provides representation services across the EU, UK, Switzerland, USA, and Australia.
Source
“They offer comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia.”
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Acts as an EU Representative for General Data Protection Regulation (GDPR) compliance.
Source
“all Processors / Controllers operating outside the European Union (EU) who handle personal data of individuals within the EU... must appoint a EU Representative – General Data Protection Regulation (GDPR).”
Certifications & Trust Signals
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Mandated to act on behalf of manufacturers by EU authorities for device placement on the market.
Source
“The European Authorized Representative (EC REP or AR) is required by the European (EU) authorities for Medical Device & IVD manufacturers located outside Europe.”
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Ensures compliance with EU MDR (EU) 2017/745 and IVDR (EU) 2017/746 for CE marking.
Source
“according to the European Medical Device Regulation – MDR (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation – IVDR (EU) 2017/746 to fulfill one aspect of the requirements for CE marking.”
Buyer Snapshot
Best for
- Non-EU medical and IVD device manufacturers
- Companies needing GDPR representation in the EU
How engagement typically works
- Mandated representative services
- Regulatory compliance support
Typical deliverables
- EU Authorized Representative services
- GDPR Representative services
- CE marking compliance support
Good to know
- Best when the manufacturer is not established in an EU Member State.
HQ:
Schleswig-Holstein, Germany
Languages:
English, German
Timezones:
Europe/Berlin
Claim status:
Listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
DE, AT, NL, BE, FR, IT, ES
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 7,000
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)
Alternate Names:
EC REP, AR
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
Germany
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
gdpr_art27_rep
gpsr_rep
Jurisdictions:
EU
Coverage:
EU
Supports Incident Reporting:
Yes
EU Entity Country:
Germany
Additional eu_ar Details
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
EU or EEA
Vigilance Contact Support
Yes
Onboarding Steps
Requires a written mandate agreement between the manufacturer and the authorized representative.
Fsca Recall Support
No
Post Market Support
No
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