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Obelis S.A. Obelis European Authorized Representative Center
Boulevard Brand Whitlock 30,
1200
Bruxelles
Belgium
Belgium
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This company is co-exhibitor of
Agence Bruxelloise pour l'Accompagnement de l'entreprise - hub.brussels
Contact
Marika Zielinska
Senior Consultant
Business Development
Business Development
Our range of products
Product categories
- 07 Medical services and publications
- 07.07 Professional institutions
Professional institutions
- 07 Medical services and publications
- 07.10 Consulting services for health organisations
Consulting services for health organisations
- 07 Medical services and publications
- 07.16 Certification and testing of medical devices, quality assurance
Certification and testing of medical devices, quality assurance
Our products
Product category: Consulting services for health organisations
EU Representation
Obelis is the largest center in Europe for CE Marking, European Representation and European Authorized Representative services (EC REP). With more than 30 years of business experience, we have helped more than 3,000 manufacturers from over 70 countries to place their products on the EU market. We are ISO 9001 & ISO 13485 certified and we are members of EU Associations and EU Commission Working Groups.
Non-EU based manufacturers are legally obliged to appoint Authorized Representatives in order for their products to legally circulate within the EU Market.
As your professional European Authorized Representative under the MDR/ IVDR, Obelis will:
· Review and keep available your MDR/IVDR Technical Documentation and CE Certification,
· Verify your EUMADED registration,
· Provide a Vigilance contact point,
· Enrol a Person Responsible for Regulatory Compliance,
· Continuously ensure your MDR/ IVDR compliance.
We register your medical devices & IVDs in Europe in 8 working days!
Non-EU based manufacturers are legally obliged to appoint Authorized Representatives in order for their products to legally circulate within the EU Market.
As your professional European Authorized Representative under the MDR/ IVDR, Obelis will:
· Review and keep available your MDR/IVDR Technical Documentation and CE Certification,
· Verify your EUMADED registration,
· Provide a Vigilance contact point,
· Enrol a Person Responsible for Regulatory Compliance,
· Continuously ensure your MDR/ IVDR compliance.
We register your medical devices & IVDs in Europe in 8 working days!
Product category: Consulting services for health organisations
MDR & IVDR Consultant
The MDR introduces a complete set of new requirements which require on average 18 months of preparatory work to achieve compliance – with only 6 months to the Date of Application (DoA), manufacturers must ensure they have taken all necessary actions!
The deadline to comply under the MDR is May 2021 or after the expiration of CE Certificate issued under MDD 93/42/EEC (only valid for legacy devices)!
We ensure your continuous MDR & IVDR compliance!
Our EU Consultancy Service include:
The deadline to comply under the MDR is May 2021 or after the expiration of CE Certificate issued under MDD 93/42/EEC (only valid for legacy devices)!
We ensure your continuous MDR & IVDR compliance!
Our EU Consultancy Service include:
- European Authorized Representative
- MDR/ IVDR Consultant
- Technical File compilation & review
- MDD 1 Notification
- Notified Body Selection
- National Device Registration
- IVD Notification
- Vigilance
- Consultancy & Updates
- Product Classification
- Free Sales Certificate
- Essential Requirements Checklist
- Identification of Standards
- Clinical Evidence
- UK Representative
- Trade Mark Sumbission
Product category: Consulting services for health organisations
UK Responsible Person
As of January 1st 2021, non-UK based manufacturers will become legally obliged to designate a UK Responsible Person to place their devices on the UK market.
As your UK Responsible Person, Obelis UK Ltd. will:
As your UK Responsible Person, Obelis UK Ltd. will:
- Register devices with MHRA,
- Ensure technical documentations have been drawn up,
- Keep a copy of technical documentations for inspection,
- Cooperate and provide MHRA all information upon request,
- Inform the manufacturer of complaints and incidents,
- Represent the manufacturer
Company news
Date
Topic
Download
Nov 17, 2020
Belgium has identified a list of COVID-19 critical devices, which devices are on the list?
The COVID-19 global pandemic has severely affected national health systems, which have therefore experienced an unprecedented crisis. Hospitals often had to cope with the fact that purchasing medical devices is not as immediate as it was in the past. The increased worldwide demand and the borders closures have led to significant delays in the procurement of devices.
Nov 16, 2020
IVDR: MDCG Guidance on Classification Rules for in vitro diagnostic medical devices released!
The MDCG published a very important document for all IVD manufacturers, as well as for notified bodies and health institutions, which shall provide guidance on the classification rules under the IVDR – Regulation (EU) 2017/746, namely its Annex VIII – while noting that the regulatory text and the MDCG Guidance shall be read jointly.
Nov 12, 2020
Building a European Health Union: medical device shortage addressed
The European Commission presented its new Communication Building a European Health Union: Stronger crisis preparedness and response for Europe and three Proposals for a Regulation to strengthen the EU’s health security framework, and to reinforce the crisis preparedness and response role of key EU agencies.
Oct 20, 2020
EUDAMED – Actor registration: new Commission webpage with important guides & templates
The European Commission has launched a new webpage dedicated to the Actor registration module of EUDAMED, where it confirmed that the actor registration module will be available to Member States and economic operators from 1 December 2020.
About us
Company details
Obelis Group is a leading specialist in European regulatory, directive, and compliance strategy. Its CE marking, responsible person, authorized representative, and consultancy services have helped countless European and non-European manufacturers alike introduce products successfully to the EU market.
Founded in 1988, the Obelis Group of companies (including Obelis European Authorized Representatives Center and Obelis European Responsible Person Center) operate as one of the largest regulatory and compliance centers in Europe. It is also a veteran member of the EAAR (European Association of Authorized Representatives) and a founding member of the ERPA (European Cosmetics Responsible Person Association).
Medical & In-Vitro Devices
As an EU leader in healthcare device regulation, Obelis offers full Authorized Representative services as well as consultancy and guidance on: MDR & IVDR, technical file creation and review, EUDAMED registration, UK representation, IVD notification, Notified Body selection, market notification and vigilance, product classification, free sales certificates, identification of standards and essential requirements, risk management, CE marking, clinical evidence, and trade mark submissions, national device registration.
Full EU Compliance
Obelis’ services cover many of the New Approach European Directives (those making CE marking or an authorized representative mandatory for products). Obelis is a market expert in CE marking and compliance for machinery, personal protective equipment, pressure equipment, radio and telecommunications equipment, electrical equipment, low voltage equipment, and toys, with a strong emphasis on cosmetics and medical and in-vitro devices.
Talk to us or visit www.obelis.net!
Founded in 1988, the Obelis Group of companies (including Obelis European Authorized Representatives Center and Obelis European Responsible Person Center) operate as one of the largest regulatory and compliance centers in Europe. It is also a veteran member of the EAAR (European Association of Authorized Representatives) and a founding member of the ERPA (European Cosmetics Responsible Person Association).
Medical & In-Vitro Devices
As an EU leader in healthcare device regulation, Obelis offers full Authorized Representative services as well as consultancy and guidance on: MDR & IVDR, technical file creation and review, EUDAMED registration, UK representation, IVD notification, Notified Body selection, market notification and vigilance, product classification, free sales certificates, identification of standards and essential requirements, risk management, CE marking, clinical evidence, and trade mark submissions, national device registration.
Full EU Compliance
Obelis’ services cover many of the New Approach European Directives (those making CE marking or an authorized representative mandatory for products). Obelis is a market expert in CE marking and compliance for machinery, personal protective equipment, pressure equipment, radio and telecommunications equipment, electrical equipment, low voltage equipment, and toys, with a strong emphasis on cosmetics and medical and in-vitro devices.
Talk to us or visit www.obelis.net!
Company data
Foundation1988
Area of businessMedical Services and Publications