THE NEW
CE MARKING
U.S. AGENT SERVICES TO THE FDA
European Authorized Representative for Medical Device Companies
An Authorized Representative is a person or a legal entity in the European Community who by designation of a manufacturer acts on their behalf. An EU Authorized Representative may be addressed by authorities and bodies within the Community, instead of the manufacturer themselves, with regards to the requirements of the EU directives Directive.
Brexit News!
MDSS-UK RP Ltd. is established!
Take advantage of
the MDR delay!
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 manufacturer. Without a U.S. facility, you will be unable to register your facility, list your products, or submit FDA marketing authorization applications without a designated a U.S. Agent.
MDSS is your Authorized Representatives For
- Medical Devices (MDR)
- In Vitro Diagnostic Devices (IVDR)
- 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) will put your company on the forefront of European Regulatory Requirements.
EUROPEAN AUTHORIZED REPRESENTATIVE (EC REP)
EU Authorized Representative for Medical Devices (MDR (EU) 2017/745) and In Vitro Diagnostic Devices (IVDR (EU) 2017/746)
U.S. AGENT
A registered U.S. Agent provides services and assistance for the U.S. Registration required by the FDA to non-U.S. based Medical Device, IVDD, and Pharmaceutical companies.
UK RESPONSIBLE PERSON
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.
Select MDSS as Your UK Responsible Person
Medical Device Manufacturers located outside the UK must use a UK Responsible Person.
EU REPRESENTATIVE - GENERAL DATA PROTECTION REGULATION (GDPR)
Being located outside the European Union, while serving EU clients and customers, requires a EU data protection 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.
CONSULTING
The consultancy team of MDSS Consulting GmbH offers many years of experience in the interpretation and implementation of regulatory requirements worldwide.
COSMETICS
As your Cosmetics Responsible Person (RP), MDSS will be your legal representative in Europe and the initial point of contact for European authorities.
MDSS SPECIALIZES IN EUROPEAN REGULATORY AFFAIRS, YOUR AUTHORIZED REPRESENTATIVE - 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.
Covid-19 Notice
Upcoming News & Views to be published on YouRegulate!
Click here to be redirected to the YouRegulate website (supported by MDSS)! There you will find all relevant information to enable your daily work in the regulatory field! Contact us if you have any question....
Q & A – new Manufacturer Incident Report (MIR) Form
In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website. The form introduced novel information requirements such as use of IMDRF advers...
Regulation (EU) 2017/745 – Consolidated text!
The consolidated text also includes the MDR delay. From now on we would not expect any major changes anymore. Consolidate text (EN).pdf For other languages click here....
Exciting developments regarding Harmonized Standards!
M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices...
Revised list of IMDRF codes also includes Annex G (component codes)
The International Medical Device Regulatory Forum (IMDRF) published the last piece of a code system which may be used worldwide for various applications. In Europe the code system is needed for notifying incidents with the Compete...
New MDCG guidance documents!
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG)...
COVID-19 info!
European Commission Comments for Consideration on COVID-19 In Vitro Diagnostic Tests and Their Performance Commission Working Document – Current Performance of COVID-19 Test Methods and Devices and Proposed Performance Crite...
MDR Delay!
2020.04.24 In writing and set in stone with the publication on the Official Journal of the European Union. Here is the publication. 2020.04.20 On Friday, April 17, 2020, the European Parliament approved to delay by one year the EU...
European Parliament votes in favor for MDR 1 year delay!
On Friday, April 17, 2020, the European Parliament approved to delay by one year the EU Medical Device Regulation with 693 votes in favor, 1 against and 2 abstentions. A great support! HOWEVER, the proposal now has to be approved ...
No CE marking needed!
On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 crisis. Those are Products covered by Regulation (EU) 2016/425 on personal protectiv...
New and current standards have been harmonized with the current directives!
On 25 March 2020, the Commission adopted three Implementing Decisions on harmonised standards which will allow manufacturers to place on the market devices that play a pivotal role in the current coronavirus pandemic: for MDD 93:4...
New documents published by the European Commission!
We will comment based on the feedback and questions MDSS may receive. State of play of joint assessments of Notified Bodies in the medical device sector.pdf MDCG 2020-1 Guidance on Clinical Evaluation (MDR) : Performance Evaluatio...
Statement on Covid-19
The Covid-19 outbreak is rapidly changing lives and business practices worldwide. Increasingly stricter measures are being implemented to protect public health. During these difficult times the safety and well-being of our familie...
Warning – For risk class I devices!
Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some clients seem to be under the impression that there was an extension given until May 2024 due to the MDR second corrigendum.Â...
Standards free of charge!
CEN and CENELEC make European standards freely available relevant for the crisis. Â Standards are created by standard organizations who carefully draft those. It sometimes takes several years of negotiations until a standard sees ...
Notified body number 11!
The notified body (NB) designation is moving along. Congratulation to NSAI. We have to note the scope NSAI shows as one of the smaller notified bodies. It includes active implantable medical devices. Well Done! However, we like to...
Brexit Deal! Business as usual! Until when??
There are no change in business in the UK with the current Brexit Deal in place (Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Commun...
Grace Period offered for products who lose the notified body without fault!
Guidance was always in place in the EU for a Grace Period (GP). However, it is always up to the member states (MS) to follow a guidance. The MHRA has applied GPs but commits itself now with a solid process. Other countries hav...
Agenda of the MDCG and the MDCG subgroups has been released!
The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined in Article 105 (see below). Â Most likely we will see an increase of new documents and hopefully new notified bodi...
For risk class I manufacturer!
Warning: No additional  transition for risk class I products.  Products who are risk class I and stay of risk class I must fully comply to the MDR by May 2020. Please consider the MDCG guidance Guidance Notes for Manufa...
MDR deadline for risk class I Manufacturers – Ready to appoint MDSS as your MDR EC REP?
The MDR deadline for Manufacturers of risk class I products is approaching. The days until May 26, 2020 are numbered! It is fundamental that class I Manufacturers prioritize their MDR compliance in order to ensure a smooth transit...
The UK never ending story comes to an end!
We published a Brexit News & Views beginning of October for our clients to react, if needed, should a hard Brexit occur, which was on the horizon at that time. Since then the core message has not changed. The importer in the ...
Use of Symbols to Indicate Compliance with the MDR!
MedTech Europe issued in December an update on the List of Symbols.pdf, which may be useful to consider in particular for the transition to the MDR. For example it provides the indication that a device is a medical device. As alw...
New documents published by the Commission!
–Â The European Medical Device Nomenclature (EMDN)Â – the nomenclature of use in EUDAMED! The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical ...
Second Corrigendum to the MDR and IVDR
This update gives certain Class I manufacturer a break. On December 27 the second corrigendum was published in the official Journal of the EU. This update was indeed needed, otherwise with the lack of notified bodies (NB) the Euro...
New Guidance published by the Commission!
The  two  new  Regulations  on  medical  devices  745/2017 (MDR) and  746/2017  (IVDR)(hereafter called the Medical DevicesRegulations) have been adopted and entered into force on 25 May 2017. The two Regulations, which a...
MDR Transition!
Plan with your EC REP to get your products ready to market by May 2020. The deadline is approaching quickly and EC REPs resources need to be allocated. Clients submitted their MDR transition plans considering as well the MDSS res...
IMPORTANT, Important … Guidance for class I manufacturer!
MDCG 2019-15 – Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December. And other guidance have been published which are also important. MDCG 2019-14 Explanatory note on ...
New Vigilance documents published on the European Commission website!
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 guidance (if applicable): Cardiac ablation vigilance reporting gui...
European Commission offers Guidance on UDIs!
Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device identifiers (UDIs). GS1 Basic UDI-DI HIBCC Basic UDI-DI ICCBBA UDI HRI & AIDC...
Total excitement on social media because of MDR Corrigendum!
In Europe the regulatory community follows closely the latest MDR developments. The rumors, that certain class I products may receive a significant extension, was substantiated last week with the proposal of a second corrigendum. ...
NO INDEPENDENT UK RESPONSIBLE PERSON (RP) POSSIBLE!!!
Brexit and Medical Devices UK RESPONSIBLE PERSON = IMPORTER What we already evaluated was strongly confirmed by a representative of the UK MHRA. And more importantly it was stated that no independent UK RP is possible. Please see...
Guidance on software classification & other documents
The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued frequently. It is great that long awaited clarification is being provided! However, stakeholder crit...
Free of charge MDR Authority meeting!
As it seems the Authority of Denmark is concerned with the MDR and provides guidance on the new Regulation. Obtain a detailed guidance for the upcoming changes. As well as Guidance about requirements and processes regarding applic...
Brexit – Again!
If you come from the latest Brexit news here is the link back to the article you were reading. UK Responsible Person = Importer with severe additional responsibilities The MDSS solution: Have MDSS set up an appointment with you ...
New information on expert panels published
The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies and manufacturers in technical, scientific and clinical aspects. Now a decision...
Another update on UK guidance!
Published September 3. We will review this new update and check whether it effects our Responsible Person (RP) contract and update accordingly if needed. Please review for yourself. Clarification is definitely needed because the p...
It`s about time…
It is about time to start YOUR MDR/IVDR project. Even though the whole world is lamenting about the new Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR), it will not help. The deadline will ...