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.
* Offers services including National Registration, Free Sales Certificate, and Importer of products.
**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.
* Offers services including National Registration, Free Sales Certificate, and Importer of products.
**Reputation / proof points**
* Over 30 years of experience in regulatory affairs for medical and in-vitro diagnostic devices.
Additional information
MDSS (EC REP) emphasizes its role in ensuring compliance with key EU regulations such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). For non-EU manufacturers, appointing an EC REP is a mandatory step to place devices on the EU market. MDSS also highlights its function as a GDPR representative, mandated to act on behalf of controllers or processors outside the EU concerning data processing activities of EU residents. This dual focus allows them to support companies with both product compliance and data protection requirements.
Key Highlights
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Specializes in regulatory affairs for medical and in-vitro diagnostic devices.
Source
“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.”
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Acts as an EU Authorized Representative (EC REP) for non-EU manufacturers to place devices on the EU 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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Provides GDPR representation for companies outside the EU handling personal data of EU residents.
Source
“According to Article 27 of the GDPR, all Processors / Controllers operating outside the European Union (EU) who handle personal data of individuals within the EU and are offering goods or services to EU residents or monitoring their behavior within the EU, must appoint a EU Representative”
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Offers 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.”
Certifications & Trust Signals
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Over 30 years of experience in regulatory affairs.
Source
“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.”
Buyer Snapshot
Best for
- Non-EU medical and IVD device manufacturers seeking EU market access.
- Companies needing a GDPR representative for EU data processing activities.
How engagement typically works
- Mandated representative for regulatory compliance.
- Point of contact for authorities and data subjects.
Typical deliverables
- EU Authorized Representative services.
- GDPR Representative services.
- Support for CE marking requirements.
- National Registration and Free Sales Certificates.
Good to know
- Best when manufacturers are located outside the EU/EEA.
- Requires a formal mandate agreement between the manufacturer and MDSS.
HQ:
Schleswig-Holstein, Germany
Languages:
English, German
Timezones:
Europe/Berlin
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
Additional eu_ar Details
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Germany
Vigilance Contact Support
No
Onboarding Steps
Requires designation and written acceptance of a mandate by the authorized representative, valid for devices of the same generic device group.
Fsca Recall Support
No
Post Market Support
No
