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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.

Meet Obelis Representatives @ MEDICA 2013

For more than 40 years Medica Exhibition is being a definite event for the medical sector that is organized each year in Düsseldorf, Germany. In November, 2013 Obelis will …

Read more: Meet Obelis Representatives @ MEDICA 2013

Obelis s.a. is Celebrating its 25th Anniversary!

This year on Friday, 27th of September, Obelis s.a. is celebrating its 25th anniversary ! I am proud and honored to have reached this unique milestone in the company’s …

Read more: Obelis s.a. is Celebrating its 25th Anniversary!

Regulatory updates on the standard EN 980

The European Commission (EC) has published on January 24th, 2013, the list of EU Harmonized standards applicable to medical devices. It appears that two harmonized standards have gone missing: …

Read more: Regulatory updates on the standard EN 980

Public workshop by EC on NEW medical device regulations

The NEW proposals for regulations for medical devices and in-vitro diagnostics medical devices, adopted by the European Commission last September (proposal 2012.541  & proposal 2012.542) were discussed at a …

Read more: Public workshop by EC on NEW medical device regulations

Obelis visiting @ IDS

Obelis European Authorized Representative Center (OEARC)  is pleased to announce its attendance in the 35th International Dental Show organized in Cologne, Germany between 14th - 15th March, 2013. Obelis …

Read more: Obelis visiting @ IDS

Ireland EU Presidency, to influence Medical Device Regulations

On January 1st 2013, Ireland took over the presidency of the Council of the European Union under the presidency trio of 2013-2014 (Ireland, Lithuania & Greece). Ireland presidency will …

Read more: Ireland EU Presidency, to influence Medical Device Regulations

Obelis visting @Arab Health Dubai

Obelis European Authorized Representative Center (OEARC) , is pleased to announce its attendance in the 38th Arab Health show, organized in Dubai, UAE; Obelis European Authorized Representative Center (OEARC), …

Read more: Obelis visting @Arab Health Dubai

Code of Conduct for Notified Bodies?

TEAM-NB is the European Association of Notified Bodies for Medical devices. It is a non-profit organization which its members are Notified Bodies (EU bodies accredited to certify for CE …

Read more: Code of Conduct for Notified Bodies?

How and whether to Audit Authorized Representatives?

TEAM-NB is the European Association of Notified Bodies for Medical devices. It is a non-profit organization which its members are Notified Bodies (EU bodies accredited to certify for CE …

Read more: How and whether to Audit Authorized Representatives?

How to select a Notified Body?

Notified Bodies are organizations accredited by national EU competent authorities with the aim to support the manufacturer in carrying out conformity assessment procedures and issuing conformity certificates, supporting the …

Read more: How to select a Notified Body?

Classification - are disinfecting products medical devices?

When taking in consideration the characteristics of a disinfecting product for the purpose of product classification , claims may appear to be medical. As a consequence, manufacturers may conclude …

Read more: Classification - are disinfecting products medical devices?

Promotion & advertising rules for Medical Devices by EU Directives

At many occasions, medical device professionals are faced with uncertainty and confusion when initiating promotions of medical devices. This is due to the fact that EU legislation provides little …

Read more: Promotion & advertising rules for Medical Devices by EU Directives

Impact on the Authorized Representative by NEW medical device proposals

The new proposal on medical devices and the new proposal on in-vitro diagnostics medical devices as presented during the press conference of September 26th 2012, by the EU Commissioner …

Read more: Impact on the Authorized Representative by NEW medical device proposals

Obelis officially welcomes NEW Proposals of European Medical Device Legislation

Obelis European Authorized Representative Center (O.E.A.R.C.), 24 years in business and operating as one of the largest regulatory centers in Europe today, providing CE marking advisory services and European …

Read more: Obelis officially welcomes NEW Proposals of European Medical Device Legislation

Review of Press Conference on NEW Proposals of European Medical Device Legislation

With over 500,000 medical devices on the European market and the recent PIP fraud incident, amending the current European legal frame work on medical devices was inevitable; The revised …

Read more: Review of Press Conference on NEW Proposals of European Medical Device Legislation

Eucomed welcoming medical device proposals with reservations

Eucomed welcoming medical device proposals with reservations Eucomed, the European medical technology industry association has expressed its welcome to the adoption of the proposals for new regulations for medical …

Read more: Eucomed welcoming medical device proposals with reservations

Celebrating today 24 Years in Business

Today, 24 years ago, on September 27th 1988, Obelis s.a. was created by Mr. Gideon Elkayam. Words from Obelis C.E.O. Mr. Gideon Elkayam : ‘Looking backwards and into the …

Read more: Celebrating today 24 Years in Business

Update on Medical Device Regulations in Switzerland

The European Economic Area (EEA) is formed by the 27 member states of the European Union as well as the 3 EFTA countries, Iceland, Norway & Lichtenstein (view map …

Read more: Update on Medical Device Regulations in Switzerland

Commission Proposal for a NEW REGULATION on Medical Devices and In-Vitro Diagnostic Medical Devices

On 26th Sept, 2012 the Commission has adopted a Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation …

Read more: Commission Proposal for a NEW REGULATION on Medical Devices and In-Vitro Diagnostic Medical Devices

The EU Regulation 722/2012 on utilizing tissues of animal origin

The EU Regulation 722/2012 on AIMDD 90/385/EEC and MDD 93/42/EEC utilizing tissues of animal origin was published in the Official Journal L212 on 09 August 2012, entered into force …

Read more: The EU Regulation 722/2012 on utilizing tissues of animal origin

NEW WEEE Directive’s Affects on Medical Devices

How does WEEE apply to Medical Devices? As opposed to the WEEE Directive 2002/96/EC & 2003/108/EC, which states that Medical Devices (regulated under MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC …

Read more: NEW WEEE Directive’s Affects on Medical Devices

New WEEE Directive 2012/19/EU (Waste of Electric & Electronic Equipments) is published

What is the objective? The utmost aims of the WEEE Directive are to reduce the amount of waste electrical and electronic equipment that piles up in landfills and to …

Read more: New WEEE Directive 2012/19/EU (Waste of Electric & Electronic Equipments) is published

Post Marketing Surveillance on Medical Devices – US FDA Working Groups

Two public meetings were organized by the United States Food & Drug Administration (FDA) on post market Surveillance System and the good use of registries in post market. The …

Read more: Post Marketing Surveillance on Medical Devices – US FDA Working Groups

New lists of harmonized standards for medical devices published by EU Commission

On August 30th 2012, The EU Commission released 3 new lists of EU Harmonized Standards for medical devices under the Medical Device Directives (MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC. …

Read more: New lists of harmonized standards for medical devices published by EU Commission

NEW Amendment to the Cosmetic Product Directive (referring to hair dying products)

The currently enforced Annexes of the 76/768/EEC Cosmetic Product Directive have been amend by the 2012/21/EU Amendment Directive on 3 Aug, 2012. The revisions are in reflection to hair …

Read more: NEW Amendment to the Cosmetic Product Directive (referring to hair dying products)

Cyprus took over EU Presidency – The role of the EC Rep

The role of the rotating Presidency of the Council of the European Union is, from time to time, not perfectly clear even for a European Member State not even …

Read more: Cyprus took over EU Presidency – The role of the EC Rep

Obelis Featured on Important Suppliers Directory

Obelis European Responsible Person Center (O.E.R.P.C.) was recently featured on personalcaresuppliers.com, an important USA portal dedicated to suppliers of products in the field of personal care. The website run …

Read more: Obelis Featured on Important Suppliers Directory

ECORE Seminar by Obelis to be Launched at Cosmoprof North America

ECORE is Obelis’ exclusive brand-name for seminars dedicated to the European Regulations concerning cosmetics. Under this name Obelis European Responsible Person Center (O.E.R.P.C.) has organized several events all over …

Read more: ECORE Seminar by Obelis to be Launched at Cosmoprof North America

Revision of the IEC 60601-1 Regarding Medical Devices, 3rd Edition – NEW

The International ICE 60601-1 standard and its 3rd revision regarding the safety and effectiveness of medical electrical equipment are of crucial importance to the manufacturers of such medical devices. …

Read more: Revision of the IEC 60601-1 Regarding Medical Devices, 3rd Edition – NEW

How Can Medical Devices in Distribution Channel Comply with IEC 60601-1, 3rd edition?

Manufacturers incorporating electric components to medical devices may find a dilemma when addressing the conformity to the 3rd edition of the IEC 60601-1, in reference to medical devices already …

Read more: How Can Medical Devices in Distribution Channel Comply with IEC 60601-1, 3rd edition?

New Electronic Labeling for Medical Devices

A new Regulation (EU 207/2012) on electronic instructions for use of medical devices has been recently adopted by the European Commission and it will come into full force starting …

Read more: New Electronic Labeling for Medical Devices

New Agency for Medical Device Registration in France

On April 29th 2012, France published in its official journal about the creation of a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), …

Read more: New Agency for Medical Device Registration in France

Registration TAX on Medical Devices Cancelled by Italian MoH

Since 2007, all classes of medical devices to be sold on the Italian territory are to be registered with the Italian Ministry of Health Database allowing them access to …

Read more: Registration TAX on Medical Devices Cancelled by Italian MoH

2012 MD Workshop in Sao Paulo by EG Mont & Obelis

With a collaboration of over a decade, OBELIS and its Representative in Brazil, EG MONT, are proud to launch a resourceful workshop on the 23rd of May, 2012 in …

Read more: 2012 MD Workshop in Sao Paulo by EG Mont & Obelis

European Parliament Issued a Resolution on PIP

The PIP resolution (Poly Implant Prothese, the French company that manufactured substandard breast implants) which was proposed by The Environment and Public Health (ENVI) Committee of the European Parliament …

Read more: European Parliament Issued a Resolution on PIP

Obelis Obtains ISO 13485:2003 Certification

In addition to the ISO 9001:2008 certificate obtained since May 2001, Obelis European Authorized Representatives Center (O.E.A.R.C.) has obtained its ISO 13485:2003 certification in April 2012, attesting to the …

Read more: Obelis Obtains ISO 13485:2003 Certification

The Machinery Safety Directive 2006/42/EC

Although the revised Machinery Directive 2006/42/EC (which became applicable starting the 29th of December 2009) does not introduce fundamental modifications compared with the old Machinery Directive 98/37/EC, it does …

Read more: The Machinery Safety Directive 2006/42/EC

New MEDDEV 2.12-1/rev7 on Vigilance Systems published

The new MEDDEV 2.12-1/rev7 Guidance document released in March 2012 has updated the requirements related to the European system for the notification and evaluation of incidents and field safety …

Read more: New MEDDEV 2.12-1/rev7 on Vigilance Systems published

The Toy Safety Directive 2009/48/EC

On 30 June 2009, the European Parliament published a new directive concerning toys’ safety, the Council Directive 2009/48/EC which repealed the old TSD 88/378/EC Directive of 1988. The general …

Read more: The Toy Safety Directive 2009/48/EC

NEW Notification procedure for IVDs

By DECISION 2010/227/EU of the EU Commission, the European Databank on Medical Devices - EUDAMED - will provide a centralized EU notification for Medical Devices, In-Vitro Diagnostics Medical Devices …

Read more: NEW Notification procedure for IVDs

The CPR 305/2011/EU – Construction Products Regulation

The European Parliament published on the 9th of March 2011 the Construction Products Regulation (CPR 305/2011/EU) which is to repeal the CPD 89/106/EEC Directive. Although most of the provisions …

Read more: The CPR 305/2011/EU – Construction Products Regulation

New CE Marking website launched by EU Commission

The European Commission has announced the coming launch of the CE marking website, aimed at providing all related CE marking information, available in 24 languages. The CE marking stands …

Read more: New CE Marking website launched by EU Commission

Obelis at Cosmoprof Bologna

Cosmoprof Worldwide Bologna is one of the world’s most important international events in the beauty and cosmetics sector. Obelis has been a permanent visitor of this momentous exhibition for …

Read more: Obelis at Cosmoprof Bologna

ATEX Directive 94/9/EC for Regulating Protective Equipment

The 94/9/EC Directive regarding the Equipment and Protective systems intended for use in Potentially Explosive Atmospheres (ATEX) offers health and safety procedures that manufacturers have to take into account …

Read more: ATEX Directive 94/9/EC for Regulating Protective Equipment

EU Motor Vehicles Directive 2007/46/EC

The 2007/46/EC Directive aims at providing further safety measures for motor vehicles and their trailers and systems, components and separate technical units intended for such vehicles, by better defining …

Read more: EU Motor Vehicles Directive 2007/46/EC

Obelis Featured on Important US Community of Cosmetics Manufacturers

Obelis was recently chosen to be featured as an international partner by one of the most dynamic web communities for small cosmetics manufacturers in the USA, indiebeauty.com.  The website …

Read more: Obelis Featured on Important US Community of Cosmetics Manufacturers

Obelis presenting at US Commercial Services Webinar – NEW!

On February 29th, 2012, the U.S. Commercial Service will broadcast a webinar aimed at facilitating the U.S. cosmetic industry’s better understanding of the new European Cosmetic Regulation (1223/2009/EC) to …

Read more: Obelis presenting at US Commercial Services Webinar – NEW!

New Directive Regarding Teeth Whitening Products

The European Commission has recently issued a new Directive (Council Directive 2011/84/EU) regarding tooth whitening products, under which these are classified as cosmetics products. These were formerly classified as …

Read more: New Directive Regarding Teeth Whitening Products

New MEDDEV on Authorized Representatives

The EU Commission released a new guidance document for the European Authorized Represenatives  (EAR) last month relating to questions of application of the EC-Directives on Medical Devices. This new …

Read more: New MEDDEV on Authorized Representatives

Medical Device Regulatory Requirements For Malaysia - NEW!

Since 2005 the Medical Device Control Division (MDCD), the responsible authority within the Ministry of Health is aiming at developing a new and comprehensive regulatory framework for Malaysia’s medical …

Read more: Medical Device Regulatory Requirements For Malaysia - NEW!

Obelis s.a. @ MEDICA 2011 - Event Overview

For the last 40 years Medica Exhibition is being a definite event for the medical sector that is organized each year in Düsseldorf, Germany. In November, 2011 Obelis has …

Read more: Obelis s.a. @ MEDICA 2011 - Event Overview

Australia Regulatory Environment for Medical Devices - NEW!

The publicly accessible TGA website indicates there were more than 43,800 approvals for Medical Devices from some 6,855 National and international Medical Device manufacturers. This is a considerable large …

Read more: Australia Regulatory Environment for Medical Devices - NEW!

Initial Registration of Imported Medical Devices in China - NEW!

China’s medical devices market has been one of the fastest growing in the world, with the rate of growth in 2011 at 13.1% , as estimated by Espicom, a …

Read more: Initial Registration of Imported Medical Devices in China - NEW!

Cosmetics with small packaging space - New!

As the NEW Cosmetic Regulation EC 1223/2009 on Cosmetic products implies, a correct label is the gateway to placing your product on the European market. The Label is one …

Read more: Cosmetics with small packaging space - New!

EU Regulation on Animal by-products affects Medical Devices and Cosmetics-NEW!

Regulation 1069/2009 and Commission Regulation 142/2011 does not apply to finished products under the respective scopes of the:    - Scope of MDD 93/42/EEC    - Scope of AIMDD 90/385/EEC    - …

Read more: EU Regulation on Animal by-products affects Medical Devices and Cosmetics-NEW!

Safe Cosmetics Act of 2011 in the USA - NEW PUBLICATION

While in the European market in reference to cosmetic products is regulated and harmonized by the Cosmetics Directive 76/768/EEC and the NEW Cosmetic Regulation EC 1223/2009, the regulatory framework …

Read more: Safe Cosmetics Act of 2011 in the USA - NEW PUBLICATION

Obelis launching NEW LinkedIn Professional Groups - NEW!

Obelis is delighted to announce its new expert groups on Linkedin! For our team of professionals in Obelis, Linkedin is more than just a social media platform that helps …

Read more: Obelis launching NEW LinkedIn Professional Groups - NEW!

SCCS Guidelines Deadline on Nanomaterials - NEW!

In preparation for the entry into full force of the new Cosmetic Regulation EC 1223/2009 on July11th 2013, the European Commission is working on developing guidelines that would make …

Read more: SCCS Guidelines Deadline on Nanomaterials - NEW!

Services for Medical Device Registration in Greece - NEW!

In accordance with Greek transposition of MDD 93/42/EEC, as published in the Greek Government Gazette, number 2198, dated 2 October 2009; article 14, paragraph 1, all medical devices must …

Read more: Services for Medical Device Registration in Greece - NEW!

Indie Beauty Network (IBN) Tele-Seminar a Great Success - NEW!

The Introduction to EU Cosmetic Regulation tele-seminar took place on October 27th 2011, in association with the Indie Beauty Network (IBN) & Obelis European Responsible Person Center (O.E.R.P.C.). The …

Read more: Indie Beauty Network (IBN) Tele-Seminar a Great Success - NEW!

Services for Device Registration in LATVIA - NEW!

Background Under the Latvian Regulation No. 581 adopted on 2 August 2005 by Cabinet of Ministers, three categories of medical devices require to be registered with the State Agency …

Read more: Services for Device Registration in LATVIA - NEW!

NEW EU Directive Regarding Tooth Whitening Products - NEW!

This article comes as an update to the article “Debate on Tooth Whitening Products is Over” published in March 2010 which informed about the European Commission decision that tooth …

Read more: NEW EU Directive Regarding Tooth Whitening Products - NEW!

Initial Cosmetic Webinar to Indie Beauty Members-NEW!

After much anticipation, Obelis will be presenting an Introduction to the European Cosmetic Regulation in association with Indie Beauty Network to IBN Members placing Cosmetic products on the market …

Read more: Initial Cosmetic Webinar to Indie Beauty Members-NEW!

Cosmetic Notification between January 2012 to July 2013-NEW!

The New Cosmetic Regulation EC 1223/2009 will replace the current Cosmetic Directive 76/768/EEC and as such, the Notification requirements are aimed to be changed as well from country specific …

Read more: Cosmetic Notification between January 2012 to July 2013-NEW!

Services for Device Registration in France-NEW!

Background Under the Decree n° 2002-1221 September 30, 2002 and Decree n°2010-270 March 15, 2010, four categories of medical devices require to be registered with the French Agency for …

Read more: Services for Device Registration in France-NEW!

The Responsible Person and Cosmeto-Vigilance - NEW!

The Responsible Person serves as the focal point for all necessary undesirable effect and serious undesirable effect communication. This includes contact with manufacturer, raw material supplier, importer, distributor end …

Read more: The Responsible Person and Cosmeto-Vigilance - NEW!

Evidence of Good Manufacturing Practice - NEW!

Evidence on Good Manufacturing Practice (GMP) is one of the essential requirements of the EU Cosmetic Regulation in Europe (EC 1223/2009) in light of product placement onto the European …

Read more: Evidence of Good Manufacturing Practice - NEW!

EU Regulation & CE Marking Workshop in Sao Paulo, BRAZIL - NEW!!!

Obelis is pleased to announce that EG MONT, Obelis’ Official Representative in Brazil, in association with HI-POWER, MEDLAB, and CENIC will be conducting a workshop in Sao …

Read more: EU Regulation & CE Marking Workshop in Sao Paulo, BRAZIL - NEW!!!

Obelis Now Included as Business Service Provider by US Trade & Commerce Department-NEW

Obelis S.A. is happy to announce that it has been officially added to the US Trade & Commerce website as a Business Service Provider and Advisor.  The …

Read more: Obelis Now Included as Business Service Provider by US Trade & Commerce Department-NEW

Cosmetic products vs. Medicinal products – Classification guidelines

For an in-depth and comprehensive reading of the guidance document on Classification guidelines between Cosmetics & Medicinal products – this guidance document may be found on our Legislation web …

Read more: Cosmetic products vs. Medicinal products – Classification guidelines

Obelis Launching EUCORE 5 Workshop – Safety Assessment (Toxicological Assessment)

Obelis Launching EUCORE 5 Workshop – Safety Assessment (Toxicological Assessment) EUCORE 5 is organized by Obelis European Authorized Representative Center (O.E.A.R.C.) together with the Federation of Israeli Chambers of …

Read more: Obelis Launching EUCORE 5 Workshop – Safety Assessment (Toxicological Assessment)

EU Market, Timeline & Harmonization

EU Market Timeline: 1. The European Community (1957) 2. Schengen Visa area (1985) 3. Unified European Market (1992) 4. “New Approach” (1985,1989,1993 & 2010) 5. The Euro born (2002) …

Read more: EU Market, Timeline & Harmonization

European Regulators are Using GMDN

In the past few months, more and more Medical Device Regulators (such as Ministries of Health or National Competent Authorities) have implemented the GMDN codes into their national requirements.  …

Read more: European Regulators are Using GMDN

Obelis International Offices Convention 2010- NEW!

Obelis International Offices (OIO) Background Launched in 2010, Obelis’ International Offices (O.I.O.) is a global network aimed at creating a strong & dedicated Network of International Obelis Offices.  The …

Read more: Obelis International Offices Convention 2010- NEW!

Italy Registration Update: Class I Medical Devices – NEW!

Background According to Italy’s Decree of Feb. 20, 2007,  all classes of medical devices introduced in Italy after May 1, 2007 must be registered in the Italian Ministry of …

Read more: Italy Registration Update: Class I Medical Devices – NEW!

Obelis launches NEW domains for International Markets – NEW!

As Obelis continues to grow and expand its international presence, NEW Obelis offices have been launched during 2010 under the O.I.O. (Obelis International Offices) network. As a support to …

Read more: Obelis launches NEW domains for International Markets – 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!

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!

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!

EROMED 3 - Obelis International Offices Convention - NEW!

NEW Obelis International Offices Convention Obelis has launched its new International Offices and will be hosting EROMED 3 at its home offices in Brussels, Belgium. EROMED 3 is a …

Read more: EROMED 3 - Obelis International Offices Convention - NEW!

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!

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!

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!

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!

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!

                                                          …

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



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