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European Directives
- European Directives
- AIMDD 90/385/EEC - Active Implantable Medical Devices Directive
- CE Marking 93/68/EEC
- Cosmetics Directive 76/768/EEC
- CPD 89/106/EEC - Construction Products Directive
- EMC Directive 2004/108/EC - Electromagnetic Compatibility Directive
- GPSD 2001/95/EC - General Product Safety Directive
- IVDD 98/79/EC - In-Vitro Diagnostic Device Directive
- LVD 2006/95/EC - Low Voltage Directive
- MDD 93/42/EEC - Medical Device Directive
- MSD 98/37/EC - Machinery Safety Directive
- PED 97/23/EC - Pressure Equipment Directive
- PPE 89/686/EEC - Personal Protective Equipment Directive
- R&TTE 1999/5/EC - Radio and Telecommunications Terminal Equipment Directive
- TSD 88/378/EEC - Toy Safety Directive
News
- News homepage
- 05 March 2010- Debate on Tooth Whitening Products is Over – NEW!
- 07 January 2010: Cosmetic Regulation Passes- NEW!
- 07 January 2010: New Obelis U.S. Offices- NEW!
- 07 January 2010: Toy Safety Directive Passes- Implications in Amendments- NEW!
- 1 September 2009 : Obelis launches – “EROMED” Workshop – October 2009
- 12 September 2008 : Obelis 20th Anniversary
- 14 December 2009: EUCORE Workshop 2- February 2010 - NEW!
- 14 July 2009 : Instructional CD for MDD and MSD Available
- 15 July 2009 : Deadline Extension of Italian Medical Device Registration
- 16 July 2009 : Obtaining a Free Sales Certificate with Obelis
- 23 April 2009 : 2008 Medical Device Workshop in Sao Paulo, Brazil
- 23 April 2009 : 2008 Seminar in Tel Aviv, Israel
- 23 April 2009 : CD of Essential Requirements for MDD & MSD
- 23 April 2009 : Certificate of CE Registration
- 23 April 2009 : Certificate of Cosmetics Registration
- 23 April 2009 : EU Trade Mark Services
- 23 April 2009 : European Association of Authorized Representatives (E.A.A.R.) Meetings
- 23 April 2009 : Free Sales Certificate
- 23 April 2009 : GiDoS Only Representative Services under REACH
- 23 April 2009 : GMDN Code Assistance
- 23 April 2009 : Obelis 20th Anniversary
- 23 April 2009 : Obelis Exhibiting at Medica this November, 2008
- 23 April 2009 : Obelis Goes Green - Launching GiDoS
- 23 April 2009 : Obelis’ OneLink:OneSolution
- 23 April 2009 : Placing Devices in Portugal
- 23 April 2009 : Recast of the Medical Devices Directive Public Consultation
- 23 April 2009 : Review of Contracts with Distributor in Reference to CE Regulation
- 23 April 2009 : Technical File Assistance
- 23 April 2009 : Update Medical Devices Directive 93/42/EEC - Clinical Evaluation
- 23 March 2010- Medical Devices to Comply with the PPE 89/686/EEC – NEW!
- 24 March 2010- New Directors by the EU Commission to regulate Medical Devices – NEW!
- 25 June 2009 : New AIMDD Services Available
- 25 June 2009 : CE Marking 93/68/EEC Directive Information Available
- 28 July 2009 : Classification Confirmation Services
- 28 July 2009 : Why Your Distributor Should NEVER Be Your EC Rep
- 31 July 2009 : Obelis launches – “EUCORE” Workshop – October 2009
- 4 August 2009 : Cosmetic Recast adopted Text by EU Parliament
- 6 April 2010: EUCORE Workshop 3 on GMP - EN/ ISO 22716- May 2010 - NEW!
- Commission Decision on the European Databank on Medical Devices – NEW!
- EROMED 2 workshop in Sao Paulo a Success - NEW!
- EUDAMED – the Medical Device databank in full use – NEW!
- February 22nd - MEDDEV 2.12-1 rev 6 replacing rev 5- NEW!
- February 5th, 2010- The NEW European Cosmetic Products Regulation- NEW!
- GMP - Cosmetic Manufacturers with sub-contractors – NEW!
- John L. Webster, C.Chem, MRCS joins Obelis Regulatory Experts – NEW!
- Legal Challenges at time of Non-Renewal of a CE certificate – NEW!
- Legal Framework in reference to the 2007/47/EC - after March 21st 2010 – NEW!
- March 10th, 2010- The Royal Belgian Economic Mission to Brazil!- NEW!
- New Guidance on classification has been published – NEW!
- New Portuguese National Law Transposing the 2007/47/EC announced – NEW!
- Obelis On-Site Training Services – NEW!
Services
- EAR Services, European Directive Services
- AIMDD 90/385/EEC Services
- CD of Essential Requirements for MDD & MSD
- Cosmetic 76/768/EEC Services
- CPD 89/106/EEC Services
- Device Classification Confirmation Services
- EMC 2004/108/EC Services
- Environmental Directives Services
- Free Sales Certificate Services
- GPSD 2001/95/EC Services
- IVDD 98/79/EC Services
- LVD 2006/95/EC Services
- MDD 93/42/EEC Services
- MSD 98/37/EC Services
- PED 97/23/EC Services
- Post Market Surveillance
- PPE 89/686/EEC Services
- R&TTE 1995/5/EC Services
- Services for Device Registration in Italy
- Trade Mark Services
- TSD 88/378/EEC Services
- US Agent Services
Directive Information
- European Directive Information
- Amendment 2006/42/EC
- Amendment 2007/47/EC
- Amendment for the CPD 89/106/EEC
- Clinical Investigation of the MDD 93/42/EEC (Annex X)
- Compliance with the AIMDD-90-385-EEC
- Compliance with the CE Marking Directive
- Compliance with the Cosmetics Directive 76/768/EEC
- Compliance with the CPD 89/106/EEC
- Compliance with the EMC Directive 2004/108/EC
- Compliance with the GPSD 2001/95/EC
- Compliance with the IVDD 98/79/EC
- Compliance with the LVD 2006/95/EEC
- Compliance with the MDD 93/42/EEC
- Compliance with the MSD 98/37/EC
- Compliance with the PED 97/23/EC
- Compliance with the PPE Directive 89/686/EEC
- Compliance with the R&TTE Directive 1999/5/EC
- Compliance with the TSD 88/378/EEC
- Future Amendment for the TSD 88/378/EEC
- Process for compliance with Obelis
- Process for compliance with Obelis
- Registration Procedures
- Scope of the AIMDD-90-385-EEC
- Scope of the CE Marking Directive
- Scope of the Cosmetics Directive 76/768/EEC
- Scope of the CPD 89/106/EEC
- Scope of the EMC Directive 2004/108/EC
- Scope of the GPSD 2001/95/EC
- Scope of the IVDD 98/79/EC
- Scope of the LVD 2006/95/EEC
- Scope of the MDD 93/42/EEC
- Scope of the MSD 98/37/EC
- Scope of the PED 97/23/EC
- Scope of the PPE Directive 89/686/EEC
- Scope of the TSD 88/378/EEC
- Structrure of the AIMDD-90-385-eec
- Structure of the CE Marking Directive
- Structure of the Cosmetics Directive 76/768/EEC
- Structure of the CPD 89/106/EEC
- Structure of the EMC Directive 2004/108/EC
- Structure of the GPSD 2001/95/EC
- Structure of the IVDD 98/79/EC
- Structure of the LVD 2006/95/EEC
- Structure of the MDD 93/42/EEC
- Structure of the MSD 98/37/EC
- Structure of the PED 97/23/EC
- Structure of the PPE Directive 89/686/EEC
- Structure of the R&TTE Directive 1999/5/EC
- Structure of the TSD 88/378/EEC
- The 1223/2009/EC
- The Directive
Publications
- Amendment to 90/385/EEC, 92/42/EEC & 98/8/EC
- Appointing A European Authorized Representative
- CE Marking Explained
- CE Marking for European Directives
- Class I: Sterile and Measuring Function Device
- Competent Authorities for Medical Device Directive 93/42/EEC
- Competent Authorities for the In Vitro Diagnostic Directive 98/79/EC
- Cosmetics Directive: Antitoxic centres
- Cosmetics Directive: Competent Authorities
- Directive IVD 98/79/EEC Article 9,7
- EMC Marking and Labeling Workbook For Sale
- EMC Workbook order form
- EMC: Notified Bodies
- Equipment Emitting Electromagnetic Waves 89/336/EEC CE Marking Services
- Equipment Emitting Electromagnetic Waves Competent Authorities
- Free Sales Certificate
- General Product Safety Directive 2001/95/EC
- General Product Safety Directive 2001/95/EC Competent Authorities
- General steps for TSD CE Marking
- In Vitro Diagnostic Directive(IVD) 98/79/EC Annex II
- IVD 98/79/EC Annex I § 8 excerpt
- IVD 98/79/EC Annex III excerpt
- IVD 98/79/EC Annex IV excerpt
- IVD Annex II: List of Devices
- IVD: Conformity Assessment Procedures
- IVD: Need of CE Marking
- Launching Gidos s.p.r.l- Green Regulatory Center
- List of Bodies Notified Under Directive: 93/42/EEC Medical devices
- List of Notified bodies under Directive 98/73/EC Machinery
- Low Voltage Directive 73/23/EEC Notified Bodies
- LVD: 72/23/EEC Structure
- LVD: General steps
- LVD: Need of CE marking
- MDD - IVD: Need of CE Marking
- MDD 93/42/ECC Annex I 13.3 excerpt
- MDD 93/42/ECC Annex VI excerpt
- MDD 93/42/ECC Annex VIII excerpt
- MDD 93/42/ECC Article 4.4 excerpt
- MDD Class I: Non Sterile Devices
- MDD Conformity Assessment Class II A
- MDD-Conformity Assessment-Class III
- MDD-Conformity-Assessment-Class II B
- MDD: Conformity Assessment Procedures
- Medical Device Directive Seminar in Tel Aviv, Israel
- Medical Device Directive Workshop in Sao Paulo, Brazil
- Medical Device Registration in Italy
- More About CE Marking
- Non European Cosmetic 76/768/EEC Manufacturers
- Non European In Vitro Diagnostic Medical Manufacturer
- Non European Machinery, Subassembly and Component Manufacturers
- Non European Medical Device Manufacturers
- Non European Personal Protective Equipment Manufacturers 89/686/EEC
- Non European Toy Directive 88/378/EEC Manufacturers
- Non-european manufacturers of equipment emitting electromagnetic waves
- Notification Procedure For Non-European Cosmetic Manufacturers
- Notified Bodies for Machinery Directive 98/37/EC
- Notified Bodies for Medical Device Directive 93/42/EEC products
- Notified Bodies for the In Vitro Diagnostics Directive 98/79/EC Products
- Only Representative
- Packaging and Packaging Waste
- Personal Protective Equipment 89/686/EEC Notified Body
- PPE: 89/686/EEC Structure
- PPE: Competent Authorities
- PPE: Need of CE marking
- REACH 2006 / 1907
- RoHS 2002/95/EC
- Steps for complying with the General Safety Directive 2001/95/EC
- Steps to obtain CE Marking for your EMC Directive 89/336/EEC product
- Steps to obtain CE Marking for your IVD product
- Steps to obtain CE Marking for your Machinery Directive 98/37/EC Product
- Steps to obtain CE Marking for your MDD product
- Steps to obtain CE Marking for your PPE 89/686/EEC Directive Products
- Technical Abbreviations
- The Latest EU Regulatory Developments
- The Revision of the directives on medical devices
- The role of European Authorized Representative
- The role of Non-European Manufacturers
- The Structure of the Electromagnetic Compatibility Directive 89/686/EEC
- The Structure of the IVD Directive 98/79/EC
- The Structure of the Machinery Directive 98/37/EC
- The Structure of the Medical Device Directive 93/42/EEC
- The Structure of the Toy Safety Directive 88/378/EEC
- Third Party Representative
- Toy Safety Directive 88/378/EC Notified Bodies
- Toy Safety Directive Need of CE Marking
- TSD Competent Authorities
- Update Medical Devices Directive 93/42/EEC - Clinical Evaluation
- WEEE 2002/96/EC & 2003/108/EC
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