MDSS
European Authorized Representative (EC REP) for medical devices according to CE Regulations (MDR 2017/745 and IVDR 2017/746) and European Regulatory Affairs.
Swiss Authorized Representative (CH-REP) according to the MedDO and IvDO.
UK Responsible Person (UKRP) according to the UK MDR 2002.
U.S. Agent to the FDA.
Our 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 & Pharma Companies must designate a U.S. Agent to register 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 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
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,......
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 now official – twelve-month extension to the current standstill period on the future regulation of medical devices in......
It is confirmed. Switzerland adopted the new Regulation on In-vitro Diagnostics (IvDO), which mainly refers to the IVDR. The provisional......
The new UKCA marking is required after July 1, 2023. Manufacturers should start acting now to ensure the deadline is......
In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website. The......
Click here to be redirected to the YouRegulate website (supported by MDSS)! There you will find all relevant information to enable your daily......
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 –......
2020.04.24 In writing and set in stone with the publication on the Official Journal of the European Union. Here is......
On Friday, April 17, 2020, the European Parliament approved to delay by one year the EU Medical Device Regulation with......
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 notified body (NB) designation is moving along. Congratulation to NSAI. We have to note the scope NSAI shows as......
There are no change in business in the UK with the current Brexit Deal in place (Agreement on the withdrawal......
Guidance was always in place in the EU for a Grace Period (GP). However, it is always up to the member states......
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......
The MDR deadline for Manufacturers of risk class I products is approaching. The days until May 26, 2020 are numbered!......
We published a Brexit News & Views beginning of October for our clients to react, if needed, should a hard Brexit......
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......
This update gives certain Class I manufacturer a break. On December 27 the second corrigendum was published in the official......
The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR)(hereafter called the Medical DevicesRegulations) have been adopted and......
Plan with your EC REP to get your products ready to market by May 2020. The deadline is approaching quickly 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......
In Europe the regulatory community follows closely the latest MDR developments. The rumors, that certain class I products may receive......
Brexit and Medical Devices UK RESPONSIBLE PERSON = IMPORTER What we already evaluated was strongly confirmed by a representative of the......
The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued......
As it seems the Authority of Denmark is concerned with the MDR and provides guidance on the new Regulation. Obtain......
If you come from the latest Brexit news here is the link back to the article you were reading. UK Responsible Person......
The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies......
Published September 3. We will review this new update and check whether it effects our Responsible Person (RP) contract and......
It is about time to start YOUR MDR/IVDR project. Even though the whole world is lamenting about the new Medical......
Authorized Representative for Medical Device Companies
An Authorized Representative is a person or a legal entity who by designation of a manufacturer acts on their behalf. Your Authorized Representative is the main contact for the National Competent Authorities. An Authorized Representative may be addressed by authorities and bodies, instead of the manufacturer themselves, with regards to the requirements of the Medical Devices Regulations
Choose your solution for the MDR (EU) 2017/745 / IVDR (EU) 2017/746.
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.