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 representation services across the EU, UK, Switzerland, USA, and Australia.
**Expertise & scope**
* Serves as the EU Authorized Representative (EC REP) for medical and in-vitro diagnostic device manufacturers located outside Europe, fulfilling requirements for CE marking under 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, as mandated by Article 27 of the GDPR.
* Provides representation services for the General Product Safety Regulation (GPSR).
* Offers National Registration and Free Sales Certificate services.
* Facilitates the role of an Importer of products.
* Conducts representative services for Clinical Investigations.
* Provides UK Responsible Person services.
**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 representation services across the EU, UK, Switzerland, USA, and Australia.
**Expertise & scope**
* Serves as the EU Authorized Representative (EC REP) for medical and in-vitro diagnostic device manufacturers located outside Europe, fulfilling requirements for CE marking under 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, as mandated by Article 27 of the GDPR.
* Provides representation services for the General Product Safety Regulation (GPSR).
* Offers National Registration and Free Sales Certificate services.
* Facilitates the role of an Importer of products.
* Conducts representative services for Clinical Investigations.
* Provides UK Responsible Person services.
**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 facilitating market access for non-EU manufacturers. For medical devices, this involves appointing an EC REP to comply with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), a key aspect of obtaining CE marking. For data protection, the GDPR mandates that controllers or processors outside the EU who offer goods/services to EU residents or monitor their behavior must designate an EU Representative. MDSS (EC REP) fulfills this requirement, ensuring compliance with Article 27 of the GDPR. They are established to act as a point of contact for supervisory authorities and data subjects regarding data processing activities.
Key Highlights
-
MDSS (EC REP) has over 30 years of experience 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.”
-
Provides comprehensive in-country 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.”
-
Acts as the EU Authorized Representative (EC REP) for medical and IVD devices, fulfilling CE marking requirements under MDR and IVDR.
Source
“The European Authorized Representative (EC REP or AR) is required by the European (EU) authorities for Medical Device & IVD manufacturers located outside Europe. In order to place medical devices in the EU market, non-EU manufacturers need to appoint a European Authorized Representative (EC REP or AR) 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.”
-
Offers EU Representative services for General Data Protection Regulation (GDPR) compliance for non-EU entities.
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 – General Data Protection Regulation (GDPR).”
Certifications & Trust Signals
-
Established in the EU or EEA, and in the Union, to act as a representative.
Source
“Addresses: established in the EU or EEA; established in the Union; established in one of the Member States where the data subjects, whose”
Buyer Snapshot
Best for
- Non-EU medical and IVD device manufacturers seeking EU market access.
- Companies outside the EU needing a GDPR representative.
- Manufacturers requiring national registration or free sales certificates.
How engagement typically works
- Mandated representative for regulatory compliance.
- Point of contact for authorities and data subjects.
Typical deliverables
- EU Authorized Representative services (EC REP).
- GDPR Representative services.
- National Registration.
- Free Sales Certificates.
- UK Responsible Person services.
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 Member States
Vigilance Contact Support
Yes
Onboarding Steps
Requires a written mandate accepted by the authorized representative, valid for at least all devices of the same generic device group. The representative must be enabled to perform tasks specified in the mandate and provide a copy of the mandate to the competent authority upon request.
Fsca Recall Support
No
Post Market Support
No
⚡ Instant booking available
Appoint an EU MDR Authorized Representative in Minutes
Compare MDSS (EC REP) and other vetted providers — instant pricing, no RFQ needed.
