Obelis European Authorized Representative Center

Boulevard Général Wahis 53, 1030 Bruxelles

Telephone +32 2 7325954
Fax +32 2 7326003

This company is co-exhibitor of
Brussels Invest & Export

Trade fair hall

  • Hall 17 / D59
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 17): stand D59

Fairground map

MEDICA 2016 fairground map: Hall 17

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Company news




Oct 25, 2016

BREXIT Explained!

Brexit – What happened?

On June 23rd 2016, 52% of UK citizens voted in favour of the ‘Brexit’: Britain-Exit of the European Union. This vote comes following much political disagreement, primarily surrounding the open borders policy (free movement) of the EU. The legal process for the UK to leave the EU will be initiated only once the Prime Minister of the UK informs the Council of the European Union of this decision, which will initiate the negotiations between the EU & the UK based on Article 50 of the Treaty of Lisbon.


Export to the UK – What to expect?

Article 50 requires the ‘exit’ negotiations to be concluded within a time period of two years with a possibility of extension if both sides agree to such an extension (in case of unfulfilled negotiations).

As such, till negotiations evolve into a new treaty and the UK actually exits the European Union, it is very important to stress that for the coming years (possibly until 2020), the UK will remain part of the European Market and selling to the UK will require compliance with EU regulations (!)

However, there are different forces in play which are likely to have an impact on the ‘Brexit’ process:

UK PM resigning – the new UK government will need time to study the new situation;
UK Parliament to ratify the referendum – if the UK Parliament does not vote to ratify the referendum, the UK might need to initiate a full scale election;
Scotland and Northern Ireland vote to remain in the EU – this might mean that they will break out of the UK and join the EU (leaving only England to negotiate with the EU);
Over 80,000 laws passed in the UK under EU legislation over the past 45 years – these will need to go through ratification;
The UK wish to remain within the Single (EU) Economic Market – in spite of exiting the EU;
The EU hard position towards the UK – there is a thought that the UK will be made an example of;

Authorized Representative/ EU Responsible Person is based in the UK?

All of the above will most likely create a long period of uncertainty for manufacturers selling to Europe. Businesses should take preventive actions to ensure stability and continuity of their CE Marking and sales to the European Union.

One of the available solutions which will allow manufacturers to remain in control of their EU market is to initiate the process to replace their Authorized Representative/Responsible Person in the UK with a new provider based in the European Union (one of the remaining 27 EU member states).

For more details on the legal process to replace your legal representative in the European Union, see our videos on the Authorized Representative / Responsible Person.

If you would like to know more on cosmetics products regulatory compliance, please contact us.

More Less

Oct 18, 2016

EU to release NEW Medical Device Regulations!

In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Parliament website, reflect the position agreed by the European Parliament and the Council of the European Union.

Once in force, they will become Regulations (not Directives, as they have been so far), which means they will be legally binding throughout the European Economic Area (EEA) market without being transposed into national laws. The proposals present new provisions which will surely impact the CE Marking, as well as the EU compliance for manufacturers of medical devices and in-vitro diagnostics.

Future Expectations & Application

The regulations include many new provisions which will have an impact on the EU compliance and CE marking process for medical devices currently on the market or soon to be introduced. As the published proposals are most likely the final texts, and taking into consideration that the implementation of the new provisions will take time, it is highly advisable for manufacturers to implement the new requirements applicable to their medical devices as soon as possible in order to safeguard their EU compliance.

Texts available on Obelis website

The consolidated texts of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices are now available on the Obelis website on our Legislation page.

If you are interested in finding out more about the new provisions, feel free to consult the new regulations on our website or contact us for more information.

More Less

Oct 11, 2016

New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions

The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016.

During the Employment, Social Policy, Health and Consumer Affairs Council of the European Union of December 7th, 2015, The Luxembourg Rotating Presidency has presented an information report concerning the status of the ongoing discussions between the Council, the European Parliament and the European Commission (so called trialogues).

Status of the negotiations

So far, 5 informal meetings and 7 technical meetings have tried to reach a consensus in view of developing a common text. Nonetheless a consensus is not yet reached among the involved parties.

Even though the negotiations will be extended through 2016, marking a 4th year of discussions since the original Commission’s proposals in 2012, the agreement between the institutions is being finalized and progress has been scored on some sections of the text. For instance, Chapter I (Scope), II (Obligations of economic operators) and III (Identification and Traceability) are now fundamentally agreed among the European Parliament and the Member States.

Consequences for manufacturers

It is expected that in 2016 a fundamental progression in the definition of the final text will be achieved.

This will imply that the new regulations will be soon enforced and become the new regulatory framework for medical and in-vitro diagnostics devices in the European Union. Manufacturers will clearly have an added value in relying on the support of professionals in order to safeguard their operations in Europe.

Obelis, with its more than 27 years of experience, can offer a full range of solutions for the compliance of manufacturers with the new requirements of the European legislation and the CE marking of their products.

If you want to know more about the New Medical Devices and In-Vitro Diagnostics regulations, please contact us.

More Less