★ European Authorized Representative (EC REP) according to the MDR 2017/745 and IVDR 2017/746
★ U.S. Agent to the FDA
★ UK Responsible Person (UKRP) according to the UK MDR 2002
★ Swiss Authorized Representative (CH-REP) according to the MedDO and IvDO
★ Australian TGA Sponsor
- 1st European Authorized Representative
- 30 years of experience
- Market leader in EU, UK, Switzerland and in FSC
Take advantage of our In-Country Representation services for Medical Devices and In Vitro Diagnostic Devices
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
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
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
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
SPONSOR
AUSTRALIAN
TGA SPONSOR
Non-Australian based Medical Device Companies must appoint an Australian Sponsor to launch devices in the Australian market.
MDSS AU performs and assists with the Registration required by the TGA
Free Online Seminar
Understanding local representative requirements
News and Views
The latest news and updates on medical devices in Europe and US
Swissmedic is pleased to announce the launch of Swissdamed, a new database designed to support the implementation of Swiss......
The MHRA has announced a policy intent to recognize medical device regulatory approvals from Australia, Canada, the EU, and......
New guidelines have been released detailing the regulatory requirements for placing “legacy devices” on the Swiss market. This is essential......
Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation......
The latest guidance document from the Medical Device Coordination Group, – Guidance on content of the Clinical Investigation Plan for clinical investigations......
We’re thrilled to announce that we have received our new ISO 13485 certification from BSI, marking a significant achievement in our commitment......
Due to concerns about manufacturers facing challenges in meeting the In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements within the allotted......
DEADLINE – May 26, 2024! ACT NOW! Submitt your application to your Notified Body and keep your foot on the gas. Keep all your MDD......
The European Commission, in collaboration with Member States, has recently released two essential documents outlining language requirements under the MDR......
This Q&As document outlines the European Medicines Agency’s (EMA) perspective on critical issues related to the development and assessment of......
The Council presidency and negotiators from the European Parliament have achieved a preliminary accord on the proposal for harmonized regulations governing......
EC survey for MD and IVD manufacturers and AR on the status of the MDR/IVDR implementation! This survey is being......
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......
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 In-Country Representative in the European Union, United Kingdom, Switzerland, USA and Australia 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 (EU/UK/USA)
Looking for support?
Other Services
LEGAL REPRESENTATIVE FOR CLINICAL INVESTIGATION
Where the Sponsor of a clinical investigation is based outside the EU, they must appoint a legal representative within the EU. This representative is responsible for ensuring the Sponsor's compliance with all obligations.
EU REPRESENTATIVE - GDPR
If Processors / Controllers are located outside the EU, while serving EU customers, a EU Representative for the General Data Protection Regulation is required. Appoint MDSS as your EU Representative to comply with the Regulation (EU) 2016/679.
IMPORTER OF PRODUCTS
MDSS-Impex GmbH places devices from a third country on the European Market according to the MDR (EU) 2017/745) and IVDR (EU) 2017/746. Being part of MDSS ensures the high quality of service with 30 years of experience in the European Regulatory Affairs.
FSC AND CFS
The MDSS team provides the support during the whole process of applying for a Free Sales Certificate (FSC) / Certificate of Marketability in the EU, UK or Switzerland 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.
CONSULTING
The consultancy team of MDSS Consulting GmbH offers many years of experience in the interpretation and implementation of regulatory requirements worldwide.
COSMETICS
MDSS Cosmetics provides services as Responsible Person for the Cosmetics Representation with the EU, UK and U.S. Authorities through the Cosmetics Regulations.