Obelis S.A. Obelis European Authorized Representative Center of Bruxelles at MEDICA 2019 in Düsseldorf -- MEDICA - World Forum for Medicine

Obelis S.A. Obelis European Authorized Representative Center

Boulevard Brand Whitlock 30, 1200 Bruxelles
Belgium
Telephone +32 2 7325954
Fax +32 2 7326003
mail@obelis.net

This company is co-exhibitor of
Agence Bruxelloise pour l'Accompagnement de l'entreprise - hub.brussels

Hall map

MEDICA 2019 hall map (Hall 15): stand A30

Fairground map

MEDICA 2019 fairground map: Hall 15

Contact

Marika ZIELINSKA

Expert Consultant - Obelis Group

Phone
+32(0)2 7325954

Email
sales@obelis.net

Company news

Date

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Sep 10, 2019

CONSEQUENCES OF NON-COMPLIANCE

Full adherence to all compliance-related matters is a hugely important part of introducing a product to the European Market – or indeed maintaining its position there. Each category of CE Marking certifiable product has its own set of regulations or directives, from medical devices to personal protective equipment to toys, and electromagnetic devices to construction products and motor vehicles.

The onus is entirely on the manufacturer to demonstrate that their product is in full compliance with the relevant essential EU directives and regulations – all of which must be adhered to in advance of a CE marking being initially affixed. Some directives also call for the appointment of a Notified Body to assess compliance or product-specific issues, though this is generally only the case with high risk or safety critical products.

For products found not to be in full compliance with applicable directives and regulations, there can be a range of consequences. Consequences can involve, but are not limited to:

  • Removal of the product from the EU market temporarily
  • Removal of the product from the EU market permanently
  • Refusal of free movement of the product within the EU zone
  • Cause for restarting the compliance process
  • Loss of the product’s CE marking
  • Recall of the product from end users
  • Ban on the marketing of the product
  • Destruction of the product
The severity of the consequences can vary according to the scale of the compliance infringement and the category of the product in question. In cases where a manufacturer/distributor is located outside of Europe, all compliance information for each product must be held by an Authorized Representative with a registered address inside the European Union. As the main point-of-contact for the manufacturer/distributor, the Authorized Representative is responsible for the notification process, incident reporting, safeguarding of compliance, and representation towards European commissions, authorities, and notified bodies, as well as consulting on European regulations.

To find out more about the compliance process for a wide range of product categories, receive a free quote on Obelis’ Authorized Representative services, or for advice on CE marking in general, contact our team of regulatory experts today!

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Sep 10, 2019

DO I NEED A CE MARKING IF MY OEM ALREADY HAS ONE?

Obtaining a CE Mark should be a primary target for any manufacturer seeking to introduce their product to the European Market. In many cases, CE Marking is a mandatory compliance requirement for products, and at the same time it makes the marketing of products far easier and more attractive to consumers as they are the hallmark of compliance with European harmonized standards.

When it comes to understanding whether one should go about obtaining a CE Marking even though their OEM (Original Equipment Manufacturer) has already secured one for their product, one should first understand the important differences between OEMs (Original Equipment Manufacturers) and OBLs (Original Brand Labellers).

Original Equipment Manufacturer: An OEM is any company/manufacturer whose primary function is to supply others with products, product components, or equipment. As such, they sell their products to other companies who will in turn incorporate these products into their own brand and resell them as their own. An OEM will never place their product on the open market under their own name.

Original Brand Labeller: OBLs are those companies buying products, components, or equipment from OEMs and introducing them to the open market under their own brand name or range or products or incorporating them as parts into their own product.

The important part to note in distinguishing the two (and in turn explaining why an OBL should seek to obtain a CE Marking of their own) is that the entire onus to obtain CE Marking, under CE Marking Directive 93/68/EEC, is on the one introducing the product to the European market – in this case the Original Brand Labeller. Regardless of whether the OEM has obtained their own CE Marking or not, the OBL is still obliged to obtain CE mark on its own.

That is not to say, however, that the OEM’s job is done once the products have changed hands with the OBL. It is always advisable for the OEM also to obtain a CE Marking, as when the time comes for the OBL to seek their CE Marking, they will have all the mandatory relevant information on hand (e.g. proof that the product complies with all EC Directives and Regulations or fully completed technical documentation).

Both OEMs and OBLs operating outside the European Union must also work in tandem with a European Authorized Representative to take care of such issues as:

  • Providing a registered address in the EU
  • Making all technical documentation available to EU Authorities for inspection
  • Completing the notification process
  • Completing the registration process in regards relevant national databases
  • Incident reporting
  • Representation towards the EU Commission, EU Authorities, and Notified Bodies
If you would like more information about the CE Marking or compliance process in terms of introducing a product to the European market, or to get a quote for our European Authorized Representative services, contact us today!

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Sep 10, 2019

MDR UPDATE: NOTIFIED BODY DESIGNATIONS & FIRST MDR CE CERTIFICATE

Until this day, the European Commission announced 4 designated Notified Bodies to certify devices under the Medical Device Regulation (EU 2017/745):

1)      BSI Assurance UK Ltd

2)      DEKRA Certification GmbH

3)      IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

4)      TÜV SÜD Product Service GmbH Zertifizierstellen

BSI UK already informed the medical device community it certified the first device under the new Regulation (EU 2017/745) and issued the related CE Certificate assessing conformity with the new legal requirements.

Who will cease their operations due to the MDR?

UK Lloyd's Register Quality Assurance (LRQA)informed their clients on the cessation of its activities as Notified Body under the new regulatory framework, in addition to the Swiss QS Zürich AG and Spanish Agency of Medicines and Medical Products (AEMPS).

On the positive note, the European Commission plans to announce the designation of as many Notified Body as possible before the MDR becomes applicable in May 2020 - in view of the 52 applications already received and 33 joint assessments carried out.

Ajda Mihelcic

Deputy Manager of Publishing department

September 6, 2019

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Sep 10, 2019

MDlaw.eu: WE MAKE EUROPEAN MDR AND IVDR ACCESSIBLE!

Find all Medical Device Regulation related documents in 1 place – news, legislation, guidelines, templates and more!

MDlaw.eu was created in March 2017 as a public utility project to meet the information needs of the medical devices sector on the new regulatory framework. MDlaw.eu gathers reference documents, implementation tools including checklists, guidelines, analysis documents, as well as regulatory updates, all in a single place.

Obelis Group remains committed to raise knowledge and spread information about the European MDR and IVDR – while keeping the Platform quality-driven, neutral or balanced in terms of opinions provided. Greater comprehension of the new law will help economic operators to develop efficiently innovative medical technologies and furthermore increase product safety to the benefit of patients and users.

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Sep 5, 2019

BREXIT PREPAREDNESS IN CASE OF A NO-DEAL SCENARIO

With only 8 weeks remaining, European authorities are finalizing preparations for the withdrawal of the United Kingdom from the European Union. Considering the approaching deadline, the European Commission has published its 6th Brexit preparedness communication. The European Commission sends a strong message to all stakeholders including those in the medical device industry to prepare for a no-deal Brexit.

As remains the case, only those manufacturers complying with EU rules will be able to place their medical devices on the EU market after the UK exit day. The European Commission can conclude today that a vast part of the manufacturers has transferred their medical device certificates from UK notified bodies to a EU27 notified body. Without a deal, UK notified body certificates will become void after the withdrawal date. Remaining manufacturers are therefore recommended to relocate their certification to a notified body in one of the EU27 countries and make the corresponding adjustments to product labels.

Like EU authorities, UK authorities are making the necessary preparations for a no-deal Brexit. The UK’s guidance regulating medical devices in case of a no-deal scenario clarifies, among others, the role of the MHRA, the applicable UK medical device legislation and the registration requirements. To ensure the supply of medical devices, UK authorities will continue to recognize the validity of CE certification by UK notified bodies achieved prior to Brexit. In the same line of thought, the UK will continue to grant access to medical devices in conformity with EU rules during a limited period after their withdrawal.

Hannah Van Deun

Research & Development (R&D) Department

September 5, 2019

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About us

Company details

Obelis European Authorized Representative (OEARC) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting European & non-European manufacturers’ successful endeavors into the European Economic Area (EEA).

With over 30 years of service, our expertise is on medical devices, in-vitro diagnostics and cosmetic products. Our mission is to be the consultant of choice, by shaping the compliance industry and providing the most effective compliance process to our customers.

Obelis (ISO 9001 and 13485 Certified), services include: CE Marking consulting, Technical File Review/Compilation, Free Sales Certificates, GMDN Code Research, Device Registrations, Trade Mark Submission, European Authorized Representative and more.

Obelis’ robust compliance network includes regulatory experts from around the world providing international regulatory support and international representation in Australia, Brazil, Canada, China, Egypt, India, Israel, Korea, Russia and the USA.

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