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Below is a list of all our content.

News

• EROMED 2 workshop in Sao Paulo a Success -  NEW!
  EROMED 2 , held on 24 May 2010, in Sao …
• GMP - Cosmetic Manufacturers with sub-contractors – NEW!
  According to EN ISO 22716 on Cosmetics — Good Manufacturing …
• Commission Decision on the European Databank on Medical Devices – NEW!
  Commission Decision of 19 April 2010 on the European Databank …
• New Guidance on classification has been published – NEW!
  The NEW Guidance Document (MEDDEV) on the classification of Medical …
• John L. Webster, C.Chem, MRCS joins Obelis Regulatory Experts – NEW!
  Obelis welcomes John L. Webster as a new member of …
• Obelis On-Site Training Services – NEW!
  Obelis is pleased to announce a new service offering dedicated …
• EUDAMED – the Medical Device databank in full use – NEW!
  What is Eudamed? – A secure web-based portal where EU …
• Legal Challenges at time of Non-Renewal of a CE certificate – NEW!
  By Dr. Peter N. Ruys – Senior Regulatory Expert for …
• Legal Framework in reference to the 2007/47/EC - after March 21st 2010 – NEW!
  By Dr. Peter N. Ruys – Senior Regulatory Expert for …
• 6 April 2010: EUCORE Workshop 3 on GMP - EN/ ISO 22716- May 2010 - NEW!
  To download the invitation and registration form CLICK HERE You …
• New Portuguese National Law Transposing the 2007/47/EC announced – NEW!
  The Portuguese Health Products Directorate (Infarmed - Autoridade Nacional do …
• 24 March 2010- New Directors by the EU Commission to regulate Medical Devices – NEW!
          The NEW people named by the …
• 23 March 2010- Medical Devices to Comply with the PPE 89/686/EEC – NEW!
      By the 2007/47/EC which came into full force …
• March 10th, 2010- The Royal Belgian Economic Mission to Brazil!- NEW!
      This year, Obelis has been invited by Brussels …
• 05 March 2010- Debate on Tooth Whitening Products is Over – NEW!
      Tooth whitening products are in fact considered cosmetics …
• February 22nd - MEDDEV 2.12-1 rev 6 replacing rev 5- NEW!
    A MEDDEV (for Medical Devices), as commonly named, is …
• February 5th, 2010- The NEW European Cosmetic Products Regulation- NEW!
        On the 30 November 2009, the European …
• 07 January 2010: Toy Safety Directive Passes- Implications in Amendments- NEW!
          On the 30th of June, 2009 …
• 07 January 2010: Cosmetic Regulation Passes- NEW!
                      …
• 07 January 2010: New Obelis U.S. Offices- NEW!
    We are proud to announce the opening of Obelis’ …
• 14 December 2009: EUCORE Workshop 2- February 2010 - NEW!
  To download the invitation and registration form CLICK HERE You …
• 31 July 2009 : Obelis launches – “EUCORE” Workshop – October 2009
  For details and registration – to download the Invitation and …
• 1 September 2009 : Obelis launches – “EROMED” Workshop – October 2009
  For details and registration (to download the invitation in English …
• 4 August 2009 : Cosmetic Recast adopted Text by EU Parliament
  Here is the provisional edition of the text adopted under …
• 28 July 2009 : Classification Confirmation Services
  News Update for Device Classification Services The first step to …
• 28 July 2009 : Why Your Distributor Should NEVER Be Your EC Rep
  Why you should NEVER appoint a distributor as your Authorized …
• 16 July 2009 : Obtaining a Free Sales Certificate with Obelis
  HOW TO OBTAIN A FREE SALES CERTIFICATE WITH OBELIS You …
• 15 July 2009 : Deadline Extension of Italian Medical Device Registration
  The Italian Ministry of Health had previously published an initial …
• 14 July 2009 : Instructional CD for MDD and MSD Available
  As you may know the 2007/47/EC amended the MDD 93/42/EEC …
• 25 June 2009 : CE Marking 93/68/EEC Directive Information Available
  The CE Marking Directive 93/68/EEC was adopted on July 22, …
• 25 June 2009 : New AIMDD Services Available
  AIMDD (Active Implantable Medical Device Directive) 90/385/EEC has been in …
• 23 April 2009 : Update Medical Devices Directive 93/42/EEC - Clinical Evaluation
  In reference to the recent changes to the MDD 93/42/EEC …
• 23 April 2009 : Recast of the Medical Devices Directive Public Consultation
  Invitation for Public Comment The Commission is considering a revision …
• 23 April 2009 : Technical File Assistance
  This service can be provided upon request by Obelis Senior …
• 23 April 2009 : Review of Contracts with Distributor in Reference to CE Regulation
  We have received concerns from many of our clients regarding …
• 23 April 2009 : GMDN Code Assistance
  The Global Medical Device Nomenclature (GMDN) provides the use of …
• 23 April 2009 : EU Trade Mark Services
  Already published in our former newsletter, we would like to …
• 23 April 2009 : Placing Devices in Portugal
  Placing your product into the European market is contingent upon …
• 23 April 2009 : Certificate of Cosmetics Registration
  Upon completion of the notification process of the Cosmetic product …
• 23 April 2009 : Certificate of CE Registration
  Upon completion of the notification process of “Class I medical …
• 23 April 2009 : Free Sales Certificate
  Many non-European countries request a personalized Free Sales Certificate from …
• 23 April 2009 : CD of Essential Requirements for MDD & MSD
  As a foundation for the implementation of the expected amendments …
• 23 April 2009 : GiDoS Only Representative Services under REACH
  Similar to the role of Authorized Representative for devices, the …
• 23 April 2009 : Obelis 20th Anniversary
  In celebration of 20 years of business excellence, Obelis hosted …
• 23 April 2009 : Obelis Goes Green - Launching GiDoS
  We are pleased to announce the launching of GiDoS s.p.r.l …
• 23 April 2009 : Obelis Exhibiting at Medica this November, 2008
  Medica World Forum for Medicine is the leading worldwide trade …
• 23 April 2009 : Obelis’ OneLink:OneSolution
  OneLink:OneSolution, Obelis’ global network, is a dynamic and quality-driven network …
• 23 April 2009 : European Association of Authorized Representatives (E.A.A.R.) Meetings
  Obelis has attended the last E.A.A.R meeting in Hannover on …
• 23 April 2009 : 2008 Medical Device Workshop in Sao Paulo, Brazil
  In reference to the expected changes in the European Directives, …
• 23 April 2009 : 2008 Seminar in Tel Aviv, Israel
  In reference to the expected changes in the European Directives, …
• 12 September 2008 : Obelis 20th Anniversary
  Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium …

Publications

• Medical Device Registration in Italy
  Synopsis of Italian Medical Device Registration “With reference to art. …
• RoHS 2002/95/EC
  The Restriction of the use of certain Hazardous Substances specifies …
• Technical Abbreviations
  This page provide a list of confusing terms that trouble …
• Third Party Representative
  Third Party Representative As a pre-registrant, you are required to …
• Only Representative
  An Only Representative will take care of your compliance and …
• The Revision of the directives on medical devices
  On the proposal for a directive of the European Parliament …
• Free Sales Certificate
  Free Sales Certificate Many non-European countries request a personalized Free …
• Directive IVD 98/79/EEC Article 9,7
  Directive IVD 98/79/EEC Article 9,7 excerpt The manufacturer must keep …
• Notified Bodies for Medical Device Directive 93/42/EEC products
  List of notified bodies under directive 93/42/EEC Medical devices: The …
• The role of Non-European Manufacturers
  If you are a medical device manufacturer located outside the …
• General steps for TSD CE Marking
  Each Device Manufacturer must develop their own compliance program which …
• Toy Safety Directive 88/378/EC Notified Bodies
  Notified Bodies are the organizations approved by the national government …
• TSD Competent Authorities
  RAPEX serves as a single European rapid alert system for …
• The Structure of the Toy Safety Directive 88/378/EEC
  The Toy Safety Directive 88/378/EEC has 16 Articles and 4 …
• Toy Safety Directive Need of CE Marking
  The European Commission does not publish a list of products …
• Non European Toy Directive 88/378/EEC Manufacturers
  The European Commissions’ directive concerning the safety of toys, 88/378/EEC, …
• PPE: Need of CE marking
  It is left up to the Manufacturer to determine the …
• PPE: Competent Authorities
  RAPEX The Rapid Exchange notification system is the official system …
• PPE: 89/686/EEC Structure
  89/686/EEC concerning Personal Protective Equipment (PPE) has 17 Articles and …
• Personal Protective Equipment 89/686/EEC Notified Body
  To establish and certify that Personal Protective Equipment meets the …
• Steps to obtain CE Marking for your PPE 89/686/EEC Directive Products
  Every Personal Protective Manufacturer must develop their own compliance program …
• Non European Personal Protective Equipment Manufacturers 89/686/EEC
  The 89/686/EEC Personal Protective Equipment (PPE) Directive covers requirements for …
• Notified Bodies for Machinery Directive 98/37/EC
  Please find below the list of Notified Bodies for Machinery …
• Steps to obtain CE Marking for your Machinery Directive 98/37/EC Product
  Each Manufacturer must develop their own compliance program which addresses …
• The Structure of the Machinery Directive 98/37/EC
  The Machinery Directive is one of the most extensive of …
• List of Notified bodies under Directive 98/73/EC Machinery
  
• MDD: Conformity Assessment Procedures
  Follow the links below to find out more about Conformity …
• MDD - IVD: Need of CE Marking
  As non-European Medical Devices Manufacturers exporting to Europe, do your …
• Steps to obtain CE Marking for your MDD product
  Each Medical Device Manufacturer must develop their own compliance program …
• Competent Authorities for Medical Device Directive 93/42/EEC
  The European Competent Authorities are the local regulating bodies in …
• The Structure of the Medical Device Directive 93/42/EEC
  The MDD is one of the most complex of the …
• List of Bodies Notified Under Directive: 93/42/EEC Medical devices
  The list of notified bodies for directive 93/42/EEC Medical devices …
• MDD Class I: Non Sterile Devices
  
• MDD Conformity Assessment Class II A
  
• MDD-Conformity-Assessment-Class II B
  
• MDD-Conformity Assessment-Class III
  
• Class I: Sterile and Measuring Function Device
  
• MDD 93/42/ECC Annex VI excerpt
  EC Declaration Of Conformity (product Quality Assurance) 1. The manufacturer …
• MDD 93/42/ECC Annex VIII excerpt
  1. The EC declaration of conformity is the procedure whereby …
• MDD 93/42/ECC Annex I 13.3 excerpt
  13.3. The label must bear the following particulars: (a) the …
• Update Medical Devices Directive 93/42/EEC - Clinical Evaluation
  Update Medical Devices Directive 93/42/EEC - Clinical Evaluation In reference …
• MDD 93/42/ECC Article 4.4 excerpt
  4. Member States may require the information, which must be …
• LVD: General steps
  Each Low Voltage Electrical Equipment Manufacturer must develop their own …
• LVD: 72/23/EEC Structure
  73/23/EEC (LVD) concerning Low Voltage Electrical Equipment currently has 14 …
• LVD: Need of CE marking
  Low Voltage Electrical Equipment is “any equipment designed for use …
• Low Voltage Directive 73/23/EEC Notified Bodies
  Notified Bodies are the organizations approved by the national government …
• Steps to obtain CE Marking for your IVD product
  Each In Vitro Device Manufacturer must develop their own compliance …
• IVD: Need of CE Marking
  The European Commission does not publish a list of products …
• IVD: Conformity Assessment Procedures
  Click to enlarge
• In Vitro Diagnostic Directive(IVD) 98/79/EC Annex II
  Official Journal of the European Communities L 331 , 07/12/1998 …
• The Structure of the IVD Directive 98/79/EC
  The IVDD is one of the most complex of the …
• Competent Authorities for the In Vitro Diagnostic Directive 98/79/EC
  The European Competent Authorities are the local regulating bodies in …
• Notified Bodies for the In Vitro Diagnostics Directive 98/79/EC Products
  The list of Notified Bodies for the In Vitro Diagnostics …
• IVD 98/79/EC Annex IV excerpt
  EC Declaration Of Conformity (Full Quality Assurance System) 1. The …
• IVD 98/79/EC Annex III excerpt
  1. The EC declaration of conformity is the procedure whereby …
• IVD 98/79/EC Annex I § 8 excerpt
  8. Information supplied by the manufacturer. 8.1. Each device must …
• Non European In Vitro Diagnostic Medical Manufacturer
  The IVDD 98/79/EC In-Vitro Diagnostic Medical Devices Directive published on …
• IVD Annex II: List of Devices
  Official Journal of the European Communities L 331, 07/12/1998 p. …
• General Product Safety Directive 2001/95/EC Competent Authorities
  DG SANCO DG Health and Consumer Protection’s goal is to …
• General Product Safety Directive 2001/95/EC
  The GPSD 2001/95/EC is designed to protect consumers from unsafe …
• Steps for complying with the General Safety Directive 2001/95/EC
  The European Council Directive 2001/95/EC on “General Products Safety” does …
• Packaging and Packaging Waste
  The Directive 94/62/EC on Packaging and Packaging Waste is the …
• EMC: Notified Bodies
  Notified Bodies Notified Bodies are the organizations approved by the …
• Equipment Emitting Electromagnetic Waves 89/336/EEC CE Marking Services
  The European Commission does not publish a list of products …
• EMC Workbook order form
  http://obelis.net/Services/Emc/emcform.php Suspendisse consectetuer nulla eget dui. Integer sem. Quisque pede …
• Equipment Emitting Electromagnetic Waves Competent Authorities
  Competent Authorities The European Competent Authorities are the local regulating …
• EMC Marking and Labeling Workbook For Sale
  Are you developing or selling a medical product that: Has …
• The Structure of the Electromagnetic Compatibility Directive 89/686/EEC
  The Electromagnetic Compatibility 89/686/EEC Directive has 12 Articles and 3 …
• Non-european manufacturers of equipment emitting electromagnetic waves
  The EMC 89/336/EEC on Electromagnetic Compatibility, mandatory since 1st January …
• Steps to obtain CE Marking for your EMC Directive 89/336/EEC product
  Each Device Manufacturer must develop their own compliance program which …
• Notification Procedure For Non-European Cosmetic Manufacturers
  
• Cosmetics Directive: Antitoxic centres
  Below is a list of antitoxic centres in Europe: Austria …
• Cosmetics Directive: Competent Authorities
  Below is a list of competent authorities relevant to the …
• Non European Cosmetic 76/768/EEC Manufacturers
  Since the introduction of the Cosmetic Directive 76/768/EEC on June …
• Non European Machinery, Subassembly and Component Manufacturers
  The Machinery Directive 98/37/EC, mandatory since 1st January 1995, covers …
• Non European Medical Device Manufacturers
  The MDD 93/42/EEC Medical Device Directive, mandatory since June 14,1998 …
• CE Marking for European Directives
  European Regulatory Language Requirements CE Marking on a product is …
• WEEE 2002/96/EC & 2003/108/EC
  The “Waste Electrical and Electronic Equipment” Directive promotes the recycling …
• REACH 2006 / 1907
  The main aims of REACH are to: Improve the protection …
• Launching Gidos s.p.r.l- Green Regulatory Center
  We are pleased to announce the launching of Gidos s.p.r.l …
• Amendment to 90/385/EEC, 92/42/EEC & 98/8/EC
  
• Medical Device Directive Seminar in Tel Aviv, Israel
  In reference to the expected changes in the European Directives, …
• Medical Device Directive Workshop in Sao Paulo, Brazil
  In reference to the expected changes in the European Directives, …
• The role of European Authorized Representative
  The 93/42/EEC Article 14 and the 98/79/EC Article 10 of …
• More About CE Marking
  What is a CE mark? A CE mark is a …
• The Latest EU Regulatory Developments
  The new directive 2007/47/EC has implications not only for manufacturers …
• CE Marking Explained
  The European Commission describes CE Marking as a “Passport to …
• Appointing A European Authorized Representative
  Crucial points to consider in appointing your “European Authorized Representative”: …