MDSS
European Authorized Representative (EC REP) for medical devices according to CE Regulations (MDR 2017/745 and IVDR 2017/746) and Regulatory Affairs.
Swiss Authorized Representative (CH-REP) according to the MedDO and IvDO.
UK Responsible Person (UKRP) according to the UK MDR 2002.
Cosmetics Responsible Person
U.S. Agent to the FDA.
Services
- 1st European Authorized Representative
- 30 years of experience
- Market leader in EU, UK, Switzerland and in FSC
EC REP
EUROPEAN AUTHORIZED
REPRESENTATIVE
Non-EU based Medical Devices Companies must appoint an EU Authorized Representative to place devices in the EU market.
MDSS GmbH assists the EU Registration with the European Authorities
U.S. AGENT
U.S. AGENT
TO THE FDA
Non-U.S. Medical Device Companies must designate a U.S. Agent to register devices with the FDA and access the US market.
MDSS USA LLC assists the US Registration required by the FDA
UKRP
UK
RESPONSIBLE PERSON
Non-UK based Medical Devices Companies must appoint a UK Responsible Person to place devices in the UK market.
MDSS-UK RP Ltd. performs and assists the UK Registration with the MHRA
CH-REP
SWISS AUTHORIZED
REPRESENTATIVE
Non-Swiss based Medical Device Companies must appoint a Swiss Authorized Representative to place devices in the CH market.
MDSS CH GmbH assists the Swiss Registration with Swissmedic
IMPORTER
IMPORTER
OF PRODUCTS
MDSS-Impex GmbH
is a company located in Germany that places medical devices from a third country on the European Market according to the MDR (EU) 2017/745) and IVDR (EU) 2017/746
COSMETICS
COSMETICS
RESPONSIBLE PERSON
MDSS Cosmetics provides services as Authorized Representative and Responsible Person for the Cosmetics Representation with the EU and UK Authorities through the Cosmetics Regulations
MDSS News and Views
The latest news and updates on medical devices in Europe and US
MedTech Europe is outlining the obstacles that medical technologies encounter within the European regulatory framework. According to the latest information,......
The European Commission released some updates regarding EUDAMED, the European Database on Medical Devices. These updates pertain to the responsibilities......
New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and......
A new version was just published. This manual serves as a valuable resource for understanding classification rules and define whether your......
There are potential advantages of conducting business in the UK. The pressing question is: Can this also be achieved within......
The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional period of......
Swissmedic released a comprehensive guidance document for the implementation of the Swiss Database on Medical Devices – swissdamed. Feel fully prepared by......
The UK Government has made a significant announcement concerning CE-marking extensions, and we want to ensure absolute clarity on the......
Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers We have some fantastic news for all medical......
UK MDR Update published! It is finally official! The Medical Devices (Amendment) (Great Britain) Regulations 2023 – statutory instrument 2023......
The UK government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023! Subject to......
The UK government is planning a substantial reform of the current regulatory framework for medical devices in the country. In......
The UK government has recently updated its guidance for CE marked medical devices in Great Britain with new information on......
Software as a Medical Device (SaMD) As a Software Medical Device (SaMD) manufacturer, you know that regulatory compliance is key......
The EU currently leads the way in regulatory standards, with the UK and Switzerland following suit. This is being done......
Swissmedic evaluated compliance declarations from a random sample of 27 Swiss manufacturers of Class I medical devices between August and......
BSI supports its clients with their own FAQ We are pleased to announce that the highly anticipated Q&A clarifying several......
EU proposes Master UDI for contact lenses The European Union has introduced a new initiative for a Master Unique Device......
On February 16, 2023, the European Parliament adopted the extension of the transition period for the EU MDR and to......
EUDAMED Production v 2.10 has been released with several new features and improvements. Are you ready for the latest and......
Key Terms and Concepts in the Medical Device Regulation – Vigilance The vigilance requirements under the EU’s medical device regulations......
MDCG guidance document on IVD classification If you’re involved in the manufacture or sale of in vitro diagnostic medical devices......
Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation The EU’s Medical Device Regulation (MDR) has brought new requirements......
Handling of Certification Gaps according to MDCG 2022-18 Introduction The Medical Device Coordination Group (MDCG) has released a new document......
Standard Fees for Notified Bodies under MDR and IVDR The Medical Device Coordination Group (MDCG) has released a new document,......
The proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746......
Article 97 – Expiring medical device certificates (Temporary application of Article 97 MDR) The Medical Devices Coordination Group’s (MDCG) position......
Products without an intended medical purpose! The regulation (EU) 2022/2346, released on 1 December 2022, lays down common specifications for......
EU MDR Bridge Deadline/transition – further info! What else happened last Friday, next to the proposed extension of the MDR......
It is confirmed. Switzerland adopted the new Regulation on In-vitro Diagnostics (IvDO), which mainly refers to the IVDR. The provisional......
In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website. The......
M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the......
The International Medical Device Regulatory Forum (IMDRF) published the last piece of a code system which may be used worldwide......
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-binding......
European Commission Comments for Consideration on COVID-19 info on In Vitro Diagnostic Tests and Their Performance Commission Working Document –......
On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark......
On 25 March 2020, the Commission adopted three Implementing Decisions on harmonised standards which will allow manufacturers to place on......
We will comment based on the feedback and questions MDSS may receive. State of play of joint assessments of Notified......
The Covid-19 outbreak is rapidly changing lives and business practices worldwide. Increasingly stricter measures are being implemented to protect public......
Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some......
CEN and CENELEC make European standards freely available relevant for the crisis. Standards are created by standard organizations who carefully......
The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined......
Warning: No additional transition for risk class I products. Products who are risk class I and stay of risk class......
MedTech Europe issued in December an update on the List of Symbols.pdf, which may be useful to consider in particular for......
– The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED! The European Medical Device Nomenclature (EMDN) will be......
The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR)(hereafter called the Medical DevicesRegulations) have been adopted and......
MDCG 2019-15 – Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December. And......
The following important vigilance documents have been published on the European website: Additional guidance on the MEDDEV 2.12/1 rev.8 Device specific vigilance......
Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device identifiers......
The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued......
The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies......
MDSS is your Authorized Representative in the European Union, United Kingdom, Switzerland and USA for:
- Medical Devices (MDR/MedDO/UK MDR 2002)
- In Vitro Diagnostic Devices (IVDR/IvDO/UK MDR 2002)
- Other European Directives & Regulations (RoHS, PPE, EMC/LVD etc.)
- Cosmetics
- FDA
Looking for support?
Other Services
EU REPRESENTATIVE - GDPR
If located outside the European Union, while serving EU customers, a EU general data protection representative is required. Use MDSS as your EU Representative to comply.
FSC AND CFS
The MDSS team provides the support during the whole process of applying for a Free Sales Certificate (FSC) / Certificate of Free Sale (CFS) / Certificate of Marketability for non-European countries.
NATIONAL REGISTRATION & GMDN CODE
Appoint MDSS to perform National Registrations on your behalf!
MDSS also offers Global Medical Device Nomenclature (GMDN) code research.
CE MARKING
Our expert team supports you from the beginning up to the successful declaration of conformity, including the affixing of the CE mark according to the European Regulations.
CONSULTING
The consultancy team of MDSS Consulting GmbH offers many years of experience in the interpretation and implementation of regulatory requirements worldwide.
MDR/IVDR SERVICES
Different solutions for manufacturers to be in compliance with the European Medical Device (MDR (EU) 2017/745) and In-Vitro Device (IVDR (EU) 2017/746) Regulations.
MDSS SPECIALIZES IN AUTHORIZED REPRESENTATION AND REGULATORY AFFAIRS - YOUR EU, UK, SWISS AUTHORIZED REPRESENTATIVE AND U.S. AGENT
- Appointing MDSS as your European Authorized Representative (EC REP) will effectively put your company on the forefront of European Regulatory Requirements.
- MDSS acts as UK Responsible Person (UKRP) and Swiss Authorized Representative (CH-REP) via our subsidiaries.
- MDSS is also specialized in FDA and provides the U.S. Agent service.