MDSS group
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.
MDSS Services
- 1st European Authorized Representative
- More than 25 years of experience
- Market leader in EU, UK, Switzerland and in FSC
EC REP
EUROPEAN AUTHORIZED REPRESENTATIVE
For Non-EU based Medical Devices Companies.
MDSS GmbH assists the EU Registration with the European Authorities
U.S. AGENT
UNITED STATES AGENT
For Non-U.S. Medical Device & Pharmaceutical Companies.
MDSS USA LLC provides services and assistance for the US Registration required by the FDA
UKRP
UK RESPONSIBLE
PERSON
For Non-UK based Medical Devices Companies.
MDSS-UK RP Ltd. provides services for the UK Registration with the MHRA
CH-REP
SWISS AUTHORIZED REPRESENTATIVE
For Non-Swiss based Medical Device Companies.
MDSS CH GmbH assists the Swiss Registration with Swissmedic
IMPORT
SERVICES
MDSS-Impex GmbH
is a company in Germany that places devices from a third country on the European Union market qualifying itself as importer
COSMETICS RESPONSIBLE PERSON
MDSS Cosmetics provides services for the Cosmetics Responsible Person Representation with the EU and UK Authorities through the Cosmetics Regulations
Medical Device News and Views
The latest news and updates on medical devices in EU and US
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......
Deadline/transition – further info! What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy......
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......
EUDAMED is online!
MDSS as your EC REP is registered – SRN number: DE-AR-000005430
Registration requirements are moving forward
European Authorized Representative for Medical Device Companies
An EU Authorized Representative is a person or a legal entity in the European Community who by designation of a manufacturer acts on their behalf. An Authorized Representative may be addressed by authorities and bodies within the European Community, instead of the manufacturer themselves, with regards to the requirements of the European Medical Devices Directives
Choose your solution for the MDR (EU) 2017/745 / IVDR (EU) 2017/746.
U.S. Agent for Medical Device & Pharmaceutical Companies.
A U.S. Agent is required by the FDA, if you are a non – U.S. based medical device manufacturer. Without a U.S. facility, you will be unable to register your facility, list your products, or submit the FDA marketing authorization applications without designating a U.S. Agent.
MDSS Group is your Authorized Representative and Responsible Person for
- Medical Devices (MDR/MedDO/UK MDR 2002)
- In Vitro Diagnostic Devices (IVDR/IvDO/UK MDR 2002)
- Cosmetics
- Other European Directives & Regulations (RoHS, PPE, etc.)
European Union Authorized Representative Services
Your EU Authorized Representative is the main contact for the European Commission and the National Competent Authorities. Appointing MDSS as your European AR (Authorized Representative) for Medical Devices (MDR (EU) 2017/745) and In Vitro Diagnostic Devices (IVDR (EU) 2017/746) will put your company on the forefront of European Regulatory Requirements.
UK Responsible Person for Medical Device Companies.
Medical Device Manufacturers located outside the UK must appoint a UK Responsible Person to place devices in the UK market. Select MDSS as Your UK Responsible Person (UKRP).
MDSS is ready to support Medical Device Manufacturers located outside the UK as trade with the UK has changed significantly. The need for a UK Responsible Person is now a requirement and MDSS understands the new UK marketplace.
Other Services
EU REPRESENTATIVE - GDPR
Being located outside the European Union, while serving EU customers, requires a EU general data protection regulation (GDPR) representative. Using MDSS as your EU Representative allows you to comply with this legal requirement.
FSC AND CFS
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!
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
The MDSS team offers 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 EUROPEAN REGULATORY AFFAIRS - YOUR EU AND SWISS AUTHORIZED REPRESENTATIVE, UK RESPONSIBLE PERSON AND U.S. AGENT - YOUR BEST ADDRESS!
An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. Appointing MDSS as your European Representative will effectively put your company on the forefront of European Regulatory Requirements.
Immediately upon implementation of the 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.