Articles

• Updated on Jan 22, 2012

  Medical Device Regulatory Requirements For Malaysia

  During the past few years the Malaysian government has been working on developing a novel regulatory system to cover medical devices. The Medical Device Control Division (MDCD), the responsible authority within the Ministry of Health, is therefore, developing and implementing the regulatory framework to manage medical devices (cosmetics are not included) …. » more
• Updated on Dec 14, 2011

  International markets attain EU Conformity through local domains

  - Obelis brings the European market closer to your business - Obelis European Authorized Representative Center (O.E.A.R.C.) objective, to support non-European manufacturers and other market players understand and as such achieve conformity with European Directives & Regulations, has always been a primary one, as only conformity shall provide access to the …. » more
• Updated on Dec 08, 2011

  Obelis s.a. @ MEDICA 2011 - Event Overview

  In November, 2011 Obelis European Authorized Representative Center (O.E.A.R.C.) has attended at Medica for the 9th consecutive year with a team of 15 representatives; For Obelis’ team of experts, MEDICA means a perfect stage to meet clients in person and observe their medical devices in reality. This personal interaction evidently facilitates …. » more
• Updated on Dec 08, 2011

  Australia Regulatory Environment for Medical Devices

  There are immense opportunities in Australia for marketing and sales of Therapeutic Products (namely medical devices and their accessories).  Since the sign off of the Mutual Recognition Agreement (MRA) with Europe and the acceptance of the CE Marking for a large proportion of Medical Devices, the importation of products into Australia …. » more
• Updated on Dec 07, 2011

  Initial Registration of Imported Medical Devices in China

  The regulatory authority that oversees the medical devices in China is the State Food and Drug Administration (SFDA). To introduce the main steps of an initial introduction of products to the Chinese market, one shall apply the official regulations, such as: Regulations for the Supervision and Administration of Medical Devices Initial …. » more
• Updated on Dec 07, 2011

  Cosmetics with small packaging space

  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 of the core elements within a cosmetic Product Information File (PIF). As presented in our article on Official EU Languages & Labeling …. » more
• Updated on Dec 01, 2011

  Animal by-products EU regulation on Medical and Cosmetic products

  Regulation EC 1069/2009 and its implementing Commission Regulation 142/2011 - in effect as of 4th March, 2011 - lay down the public and animal health rules for animal-by-products (ABPs) and derived products to prevent and minimize risks to health deriving from these products.  By definition: ‘animal by-product’ means entire bodies or …. » more
• Updated on Nov 25, 2011

  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 in the USA has not been as comprehensive and stringent till today. The current US law in effect is from 1938 and …. » more
• Updated on Nov 16, 2011

  Obelis launching NEW LinkedIn Professional Groups

  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 connecting people. It goes beyond that. Linkedin offers a higher added value through letting users gain know-how, share information or even consult …. » more
• Updated on Oct 27, 2011

  Introduction to the Central Management Committee (CMC)

  The Central Management Committee (CMC) was established during the 26th Meeting of the European Competent Authorities in Liége by the Competent Authorities within the medical devices sector. The main purpose of its creation is to improve the effectiveness and appropriateness of the regulatory system and ensure its continued development. It is …. » more
• Updated on Nov 29, 2011

  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 to the CPNP (Cosmetic Product Notification Portal) operated by the European Commission. The question is what will happen during the transitional period …. » more
• Updated on Sep 05, 2011

  The NEW RoHS 2011/65/EC Directive to apply to Medical Devices – NEW!

  The recast of the Restriction of Hazardous Substances (RoHS) Directive has been published on the official journal of the European Commission on the 8th of June 2011 as 2011/65/EU.  With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic Equipment. - Scope: …. » more
• Updated on Sep 05, 2011

  Notified Bodies & EC REP – Complementary Activities towards the CE Marking

  The CE marking is a European mark, under European law (Directives & Regulations) and as such aimed at European entities only (!) – in order to place a product within the European market, conformity with the requirements needs to be demonstrated, the CE marking affixed and a registered address within the …. » more
• Updated on Aug 29, 2011

  Manufacturer vs. Legal Claimed Manufacturer

  By European Directive & Regulations, the manufacturer is responsible for the design, manufacturing, packaging and sale of a product placed on the European market under his own name whether he is actually fulfilling those tasks or subcontracting them. European regulation categorizes entities placing products on the market under their name into …. » more
• Updated on Aug 01, 2011

  Official EU Languages & Labeling Requirements

  The last to join the European Union were Romania and Bulgaria in January 2007. Since then, the European Union numbers 27 European States in which 23 different official languages are spoken. Through this union many different regulations were harmonized among the Member States, while harmonizing language is yet to be achieved. …. » more
• Updated on Jul 26, 2011

  Free Sales Certificate by a European Authority

  According to the European Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, properly notified (if required) and CE marked medical devices are allowed to circulate and be sold throughout the European Union. Non-EU Authorities may request a Certificate of Free Sales (FSC) from the manufacturer to confirm that: …. » more
• Updated on Jul 26, 2011

  Obelis – Licensed Consultant for GMDN Codes

  Obelis– Licensed Consultant for GMDN Codes The GMDN (Global Medical Device Nomenclature) Agency, is an international non-profit organisation which has been appointed by its stakeholders, Medical Device Regulators and Industry, to manage the GMDN database and maintain the nomenclature. The Global Medical Device Nomenclature (GMDN) provides the use of generic descriptors …. » more
• Updated on Jul 26, 2011

  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) The previous EU market was very fragmented with differences in regulations, languages, currencies, market systems and passport areas which made trade …. » more
• Updated on Jul 26, 2011

  Notification of discontinuation of placing IVDs

  Background In accordance with the dispositions of the directive 98/79/EC, the European Authorized Representative (EC REP) has the obligation to inform all countries concerned of discontinuation of placing in vitro diagnostic medical devices onto the European Economic Area (EEA) in addition to the country where he has his registered place of …. » more
• Updated on Jul 26, 2011

  EU Regulation of average fill & Estimated Symbol “e”

  The small ‘e’,at least 3 mm high, placed in the same field of vision as the indication of the nominal weight or nominal volume, constitutes a guarantee by the packer or the importer that the prepackage meets the requirements of the Directive 76/211/EEC (on the approximation of the laws of …. » more
• Updated on Jul 26, 2011

  CMC decision on new format of “Address of the Manufacturer” on Labels & IFUs

  On December 1st 2010, the European Competent Authorities within the Medical Devices sector decided the creation of a Central Management Committee (CMC), aimed at harmonizing national notification procedures. Because Medical Devices are governed by European Directives, a European law concerning Medical Devices could technically be transposed in 27 different manners, …. » more
• Updated on Jul 26, 2011

  What makes up a Cosmetic Product Safety Report (CPSR)

  The Cosmetic Product Safety Report (CPSR) is a required element described in annex I of the European Regulation 1223/2009. This report includes Part A: Safety Information and Part B: Safety Assessment. The Safety Information includes qualitative and quantitative composition, intended function of substances, physical and chemical characteristics of the substances, …. » more
• Updated on Jul 26, 2011

  What is a Product Information File?

  One of the main activities of the Responsible Person is the overview of the compiled Product Information File (PIF). This includes all necessary elements according to the EU Cosmetic Regulation 1223/2009. The PIF contains a number of files including a description of the product, method of manufacture, Good Manufacturing Practice …. » more
• Updated on Jul 26, 2011

  The Role of a Responsible Person

  According to European law, each cosmetic product placed on the European market requires the designation of a Responsible Person (“RP”) to ensure compliance with the relevant obligations (EC 1223/2009 Article 4.1). This compliance includes, but is not limited to, safety, Good Manufacturing Practice, a Product Information File, sampling and analysis, …. » more
• Updated on Jul 27, 2011

  Legal Framework in reference to the 2007/47/EC - after March 21st 2010

  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 IVD. The directive 93/42/EEC has been modified 5 times in the past while the most recent amendment was via directive 2007/47/EC. …. » more
• Updated on Jul 16, 2009

  Medical Device Registration in Italy

  Synopsis of Italian Medical Device Registration “With reference to art. 14 bis European Data Bank as per 93/42/EEC Directive – 2002 Edition we inform you that on 20th February 2007, Italian Ministry of Health enacted a Ministerial Decree concerning the Registration in the Medical Device Inventory.” The above mentioned Registration into …. » more
• Updated on Dec 28, 2008

  Technical Abbreviations

  This page provide a list of confusing terms that trouble even the best of us. We hope that this page provides some insight into the world of EU regulatory Compliance. CDRH Center for Devices and Radiological Health, FDA. CE Marking CE Marking Approval marking for products being shipped into the 15 …. » more
• Updated on Dec 28, 2008

  Only Representative

  An Only Representative will take care of your compliance and obligations under REACH. This includes not only the registration, but also the authorization, classification/labeling, notification, and restrictions (where applicable) which may be necessary for your substances, as well all administrative procedures. Benefits include: Does not demand exclusivity and you are free …. » more
• Updated on Dec 28, 2008

  Free Sales Certificate

  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 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, CE marked and properly registered devices in all 27 EU member states …. » more
• Updated on Dec 28, 2008

  Directive IVD 98/79/EEC Article 9,7

  Directive IVD 98/79/EEC Article 9,7 excerpt The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates, established by Notified Bodies, and make it available to the national authorities for inspection purposes for a period ending …. » more
• Updated on Dec 28, 2008

  Notified Bodies for Medical Device Directive 93/42/EEC products

  List of notified bodies under directive 93/42/EEC Medical devices: The list of Notified Bodies can be downloaded as pdf. » more
• Updated on Dec 28, 2008

  CE Marking for European Directives

  European Regulatory Language Requirements CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called Product Directives which contain the “essential requirements” and/or “performance levels” and “Harmonized Standards” …. » more
• Updated on Dec 28, 2008

  WEEE 2002/96/EC & 2003/108/EC

  The “Waste Electrical and Electronic Equipment” Directive promotes the recycling of Electrical and Electronic Equipment (EEE) and their components at end-of-life or when being replaced. Environmentally responsible practices are encouraged among all those who are involved in the life cycle of EEE. The WEEE Directive: Mandates a number of recycling procedures …. » more
• Updated on Apr 22, 2009

  REACH 2006 / 1907

  The main aims of REACH are to: Improve the protection of human health and the environment from the risks that can be posed by chemicals Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU Promote alternative methods for the assessment of hazards of …. » more
• Updated on Dec 28, 2008

  Launching Gidos s.p.r.l- Green Regulatory Center

  We are pleased to announce the launching of Gidos s.p.r.l -Green Regulatory Center. Gidos will deal solely with matters pertaining to the compliance with the European Green Directives and Regulations and will be fully operational as of September 1st 2008. . » more
• Updated on Oct 26, 2008

  Medical Device Directive 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 2008. The seminar was a great success with over 50 participants in attendance. The seminar focused on guidelines for the first implementations of the RoHS …. » more
• Updated on Oct 26, 2008

  Medical Device Directive Workshop in Sao Paulo, Brazil

  In reference to the expected changes in the European Directives, Obelis and EG Mont Assessoria e Consultoria Ltda. have initiated a workshop in Sao Paulo, Brazil which will focus on these changes and their implications. There are two main changes that are particularly important. A decreasing of the importance of the …. » more
• Updated on Dec 27, 2008

  More About CE Marking

  What is a CE mark? A CE mark is a mark placed on products by their manufacturer that act as a statement that the product meets all the standards and requirements of the relevant legislation according to the appropriate European Directives. CE Marking gives companies easier access into the European market …. » more
• Updated on Aug 19, 2008

  The Latest EU Regulatory Developments

  The new directive 2007/47/EC has implications not only for manufacturers who sell medical devices in the EU but for the medical device industry as a whole. (I)The directive 2007/47/EC amends the following directives: AIMDD 90/385/EEC, MDD 93/42/EEC and the directive 98/8/EC concerning the placing of biocidal products on the market. Manufacturers …. » more