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Obelis European Representative News
Below highlighted is important information concerning upcoming events in relation to the European directives, Obelis' activities, and other important current events to help keep you up to date in the European market.
EROMED 2 workshop in Sao Paulo a Success - NEW!
EROMED 2 , held on 24 May 2010, in Sao Paulo, Brazil was a great success thanks to our cooperation with EG MONT of Brazil, and HI-POWER, a Brazilian …
Read more: EROMED 2 workshop in Sao Paulo a Success - NEW!
GMP - Cosmetic Manufacturers with sub-contractors – NEW!
According to EN ISO 22716 on Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices Article 12 - Subcontracting. The GMP certificate is to be issued …
Read more: GMP - Cosmetic Manufacturers with sub-contractors – NEW!
Commission Decision on the European Databank on Medical Devices – NEW!
Commission Decision of 19 April 2010 on the European Databank on Medical Devices. Articles 5 and 6 - Competent Authorities will have just under 2 years (until 30 April …
Read more: Commission Decision on the European Databank on Medical Devices – NEW!
New Guidance on classification has been published – NEW!
The NEW Guidance Document (MEDDEV) on the classification of Medical Devices has been published by the European Commission, DG HEALTH AND CONSUMER Directorate B , Unit B2 “Cosmetics and …
Read more: New Guidance on classification has been published – NEW!
John L. Webster, C.Chem, MRCS joins Obelis Regulatory Experts – NEW!
Obelis welcomes John L. Webster as a new member of Obelis European Authorized Representative Center Experts Team from 1st July 2010. John managed MDCI Ltd’s office in the UK …
Read more: John L. Webster, C.Chem, MRCS joins Obelis Regulatory Experts – NEW!
Obelis On-Site Training Services – NEW!
Obelis is pleased to announce a new service offering dedicated training sessions by our regulatory team on site at our clients’ premises. Such on-site training can be dedicated to …
Read more: Obelis On-Site Training Services – NEW!
EUDAMED – the Medical Device databank in full use – NEW!
What is Eudamed? – A secure web-based portal where EU competent authorities enter information received from manufacturers and notified bodies in order to exchange the information with the European …
Read more: EUDAMED – the Medical Device databank in full use – NEW!
Legal Challenges at time of Non-Renewal of a CE certificate – NEW!
By Dr. Peter N. Ruys – Senior Regulatory Expert for Obelis s.a. In order to place a medical device on the European Market a manufacturer needs to be in …
Read more: 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!
By Dr. Peter N. Ruys – Senior Regulatory Expert for Obelis s.a. The certification of medical devices in the EU is based upon three directives – MDD, AIMD and …
Read more: Legal Framework in reference to the 2007/47/EC - after March 21st 2010 – NEW!
6 April 2010: EUCORE Workshop 3 on GMP - EN/ ISO 22716- May 2010 - NEW!
To download the invitation and registration form CLICK HERE You may contact us or contact the Manufacturers Association offices by Tel - +972.3.5198847 CLICK HERE to download the adopted …
Read more: 6 April 2010: EUCORE Workshop 3 on GMP - EN/ ISO 22716- May 2010 - NEW!
New Portuguese National Law Transposing the 2007/47/EC announced – NEW!
The Portuguese Health Products Directorate (Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.) announced this week that the new national Decree-Law 145/2009 transposing the European Directives …
Read more: New Portuguese National Law Transposing the 2007/47/EC announced – NEW!
24 March 2010- New Directors by the EU Commission to regulate Medical Devices – NEW!
The NEW people named by the EU Commission to take care of future development of the medical device regulation in Europe has now been clarified. …
Read more: 24 March 2010- New Directors by the EU Commission to regulate Medical Devices – NEW!
23 March 2010- Medical Devices to Comply with the PPE 89/686/EEC – NEW!
By the 2007/47/EC which came into full force as of March 21st 2010, face masks may have to comply from with the essential safety requirements of the …
Read more: 23 March 2010- Medical Devices to Comply with the PPE 89/686/EEC – NEW!
March 10th, 2010- The Royal Belgian Economic Mission to Brazil!- NEW!
This year, Obelis has been invited by Brussels Export to join HRH Prince Philip in attending the Royal Economic Mission to Brazil. The Mission to Brazil is …
Read more: March 10th, 2010- The Royal Belgian Economic Mission to Brazil!- NEW!
05 March 2010- Debate on Tooth Whitening Products is Over – NEW!
Tooth whitening products are in fact considered cosmetics - It is now an official position of the European Commission. They must meet the provisions of Annex III, …
Read more: 05 March 2010- Debate on Tooth Whitening Products is Over – NEW!
February 22nd - MEDDEV 2.12-1 rev 6 replacing rev 5- NEW!
A MEDDEV (for Medical Devices), as commonly named, is a EU Guidelines document aiming to promote a common approach by manufacturers and Notified Bodies involved in the conformity …
Read more: February 22nd - MEDDEV 2.12-1 rev 6 replacing rev 5- NEW!
February 5th, 2010- The NEW European Cosmetic Products Regulation- NEW!
On the 30 November 2009, the European Parliament adopted the new Cosmetic Products Regulation, EU Regulation 1223/2009, aimed to replace the European Cosmetics Directive 76/768/EEC . …
Read more: February 5th, 2010- The NEW European Cosmetic Products Regulation- NEW!
07 January 2010: Toy Safety Directive Passes- Implications in Amendments- NEW!
On the 30th of June, 2009 the new Toy Safety Directive was published. It substantially amends the old Directive across virtually all safety aspects. It …
Read more: 07 January 2010: Toy Safety Directive Passes- Implications in Amendments- NEW!
07 January 2010: Cosmetic Regulation Passes- NEW!
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Read more: 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’ offices in the United States located in Salt Lake City, Utah as of January 7th, 2010. As one of …
Read more: 07 January 2010: New Obelis U.S. Offices- NEW!
14 December 2009: EUCORE Workshop 2- February 2010 - NEW!
To download the invitation and registration form CLICK HERE You may contact us or contact the Chamber of Commerce offices by Tel - +972.3.5631023 CLICK HERE to download the …
Read more: 14 December 2009: EUCORE Workshop 2- February 2010 - NEW!
31 July 2009 : Obelis launches – “EUCORE” Workshop – October 2009
For details and registration – to download the Invitation and Registration form CLICK HERE Please note: the registration form is on the last page of the invitation. To download …
Read more: 31 July 2009 : Obelis launches – “EUCORE” Workshop – October 2009
1 September 2009 : Obelis launches – “EROMED” Workshop – October 2009
For details and registration (to download the invitation in English – CLICK HERE): …
Read more: 1 September 2009 : Obelis launches – “EROMED” Workshop – October 2009
4 August 2009 : Cosmetic Recast adopted Text by EU Parliament
Here is the provisional edition of the text adopted under the Codecision procedure: recast by the European parliament- Strasbourg on Tuesday, 24 March 2009 The European Parliament legislative resolution …
Read more: 4 August 2009 : Cosmetic Recast adopted Text by EU Parliament
28 July 2009 : Classification Confirmation Services
News Update for Device Classification Services The first step to success in the European Union Marketplace is compliance with EU regulation. Essential to EU compliance is the correct classification …
Read more: 28 July 2009 : Classification Confirmation Services
28 July 2009 : Why Your Distributor Should NEVER Be Your EC Rep
Why you should NEVER appoint a distributor as your Authorized Representative? • As per the Directive, the E.A.R must keep available for the European Authorities the product’s technical file, …
Read more: 28 July 2009 : Why Your Distributor Should NEVER Be Your EC Rep
16 July 2009 : Obtaining a Free Sales Certificate with Obelis
HOW TO OBTAIN A FREE SALES CERTIFICATE WITH OBELIS You have two options to utilize Obelis services in order to obtain a Free Sales Certificate: 1. To sign an …
Read more: 16 July 2009 : Obtaining a Free Sales Certificate with Obelis
15 July 2009 : Deadline Extension of Italian Medical Device Registration
The Italian Ministry of Health had previously published an initial extension from the 31st December 2008 with a deadline on the 30th April 2009; which has now been further …
Read more: 15 July 2009 : Deadline Extension of Italian Medical Device Registration
14 July 2009 : Instructional CD for MDD and MSD Available
As you may know the 2007/47/EC amended the MDD 93/42/EEC which may have an immediate impact on the compliance of your medical devices in Europe. There are two main …
Read more: 14 July 2009 : Instructional CD for MDD and MSD Available
25 June 2009 : CE Marking 93/68/EEC Directive Information Available
The CE Marking Directive 93/68/EEC was adopted on July 22, 1993 and its purpose being to introduce a harmonized set of rules relating to the affixing and use of …
Read more: 25 June 2009 : CE Marking 93/68/EEC Directive Information Available
25 June 2009 : New AIMDD Services Available
AIMDD (Active Implantable Medical Device Directive) 90/385/EEC has been in place since June 20, 1990. This directive applies to devices according to Article 2.C AIMDD, which defines an active …
Read more: 25 June 2009 : New AIMDD Services Available
23 April 2009 : Update Medical Devices Directive 93/42/EEC - Clinical Evaluation
In reference to the recent changes to the MDD 93/42/EEC by its amendment the 2007/47/EC, the following needs to be brought to your attention: 1. All classes of Medical …
Read more: 23 April 2009 : Update Medical Devices Directive 93/42/EEC - Clinical Evaluation
23 April 2009 : Recast of the Medical Devices Directive Public Consultation
Invitation for Public Comment The Commission is considering a revision of the legal framework in Europe for Medical Devices in order to improve and strengthen this framework and to …
Read more: 23 April 2009 : Recast of the Medical Devices Directive Public Consultation
23 April 2009 : Technical File Assistance
This service can be provided upon request by Obelis Senior Regulatory Expert Dr. Peter Ruys. Dr. Ruys is an expert consultant in International Medical Device regulations. He is the …
Read more: 23 April 2009 : Technical File Assistance
23 April 2009 : Review of Contracts with Distributor in Reference to CE Regulation
We have received concerns from many of our clients regarding contracts with European Distributors in reference to CE Marked products. While local distributors can be helpful in circulating your …
Read more: 23 April 2009 : Review of Contracts with Distributor in Reference to CE Regulation
23 April 2009 : GMDN Code Assistance
The Global Medical Device Nomenclature (GMDN) provides the use of generic descriptors for the identification of medical devices and other Healthcare related products. More and more, the GMDN is …
Read more: 23 April 2009 : GMDN Code Assistance
23 April 2009 : EU Trade Mark Services
Already published in our former newsletter, we would like to remind you that Obelis offers from now on the possibility to register your trade mark and design in the …
Read more: 23 April 2009 : EU Trade Mark Services
23 April 2009 : Placing Devices in Portugal
Placing your product into the European market is contingent upon your compliance with the Medical Device Directive 93/42/EEC. While this Directive is a law to all 27 Member States …
Read more: 23 April 2009 : Placing Devices in Portugal
23 April 2009 : Certificate of Cosmetics Registration
Upon completion of the notification process of the Cosmetic product family, the Manufacturer can receive a Certificate of Cosmetic registration (195,00 € per original copy) authenticated by Obelis CEO …
Read more: 23 April 2009 : Certificate of Cosmetics Registration
23 April 2009 : Certificate of CE Registration
Upon completion of the notification process of “Class I medical devices” product family, the Manufacturer can receive a Certificate of CE registration (195,00 € per original copy) authenticated by …
Read more: 23 April 2009 : Certificate of CE Registration
23 April 2009 : Free Sales Certificate
Many non-European countries request a personalized Free Sales Certificate from the manufacturer in order to place their device within that specific country. According to the European Medical Device Directive …
Read more: 23 April 2009 : Free Sales Certificate
23 April 2009 : CD of Essential Requirements for MDD & MSD
As a foundation for the implementation of the expected amendments within European Directives, Obelis has created a CD containing valuable information which will assist in the implementation of these …
Read more: 23 April 2009 : CD of Essential Requirements for MDD & MSD
23 April 2009 : GiDoS Only Representative Services under REACH
Similar to the role of Authorized Representative for devices, the REACH Regulation allows and advises an Only Representative to act as the legal representative for the manufacturer in regards …
Read more: 23 April 2009 : GiDoS Only Representative Services under REACH
23 April 2009 : Obelis 20th Anniversary
In celebration of 20 years of business excellence, Obelis hosted a Obelis 20th Anniversary Ball and Garden Party, held on September 19th 2008 at Obelis corporate Offices in Brussels, …
Read more: 23 April 2009 : Obelis 20th Anniversary
23 April 2009 : Obelis Goes Green - Launching GiDoS
We are pleased to announce the launching of GiDoS s.p.r.l Green Regulatory Center. GiDoS will deal solely with matters pertaining to compliance with the European Environmental Directives and Regulations …
Read more: 23 April 2009 : Obelis Goes Green - Launching GiDoS
23 April 2009 : Obelis Exhibiting at Medica this November, 2008
Medica World Forum for Medicine is the leading worldwide trade fair in the medical industry with over 4,300 companies exhibiting each year. This year marks the 40th year of …
Read more: 23 April 2009 : Obelis Exhibiting at Medica this November, 2008
23 April 2009 : Obelis’ OneLink:OneSolution
OneLink:OneSolution, Obelis’ global network, is a dynamic and quality-driven network of international experts from independent companies that offers advanced regulatory consultation, directive assistance, language compliance solutions and new market …
Read more: 23 April 2009 : Obelis’ OneLink:OneSolution
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 the 8th and 9th of May earlier this year and hosted the very last EAAR meeting on September 2nd, …
Read more: 23 April 2009 : European Association of Authorized Representatives (E.A.A.R.) Meetings
23 April 2009 : 2008 Medical Device Workshop in Sao Paulo, Brazil
In reference to the expected changes in the European Directives, Obelis and EG Mont Assessoria e Consultoria Ltda. initiated a workshop in Sao Paulo, Brazil which focused on these …
Read more: 23 April 2009 : 2008 Medical Device Workshop in Sao Paulo, Brazil
23 April 2009 : 2008 Seminar in Tel Aviv, Israel
In reference to the expected changes in the European Directives, Obelis initiated a seminar in Tel Aviv at the Israeli Export Institute on June 22nd. The seminar was a …
Read more: 23 April 2009 : 2008 Seminar in Tel Aviv, Israel
12 September 2008 : Obelis 20th Anniversary
Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. Obelis, …
Read more: 12 September 2008 : Obelis 20th Anniversary
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