News

New MEDDEV on Authorized Representatives

in News

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 document sets important guidelines for the EARs in respect to two features:

  • It summaries the roles and responsibilities of the Authorized Representative as mentioned in the medical devices Directives (MDD/93/42/EEC; AIMDD 90/385/EEC; IVDD 98/79/EC)
  • It also describes the expectations of the European Union Member States regarding the role of the EAR concerning market surveillance.

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Obelis s.a. @ MEDICA 2011 – Event Overview

in News

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 attended at Medica Exhibition for the 9th consecutive year with a highly dedicated team, represented by the company’s Management:

• Mr. Gideon Elkayam – C.E.O.;
• Mr. Doram Elkayam – C.O.O.;
• Dr. Peter Ruys – Expert consultant in International Medical Device regulations;
• Mr. Hemi Zimmerman – Israeli Branch Manager;
• Ms. Stacy Edelen – USA Branch Manager.

img_event_Medica 2011

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Animal by-products EU regulation on Medical and Cosmetic products

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News, Publications

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 parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption (Article 3). These include: fallen stock on farms, wild animals when they suspected of being diseases, slaughterhouse waste, skins, feathers, blood, or meat, fish, milk and eggs when they are interned for human consumption. (Article 8, 9, 10);

Due to the increasing number of incidents, when serious diseases (TSE, BSE, swine fever) started to spread in a consequence of the lack of risk control, the preceding Regulation (EC 1774/2002) has been thoroughly revised. As a result, the current Regulation:

  • Gives a more comprehensive scope and more apparent framework to the Regulation;
  • Defines animal-by-products in a more transparent way;
  • Clarifies the products exempted from the control of this Regulation;
  • Improved the categorization of ABPs in line with risks:
    • Category 1 material (e.g. animals killed in the context of TSE eradication measures)
    • Category 2 material (e.g. manure, non-mineralized guano and digestive tract content)
    • Category 3 material (e.g. carcasses and parts of animals slaughtered)

Consequently, the Regulation provides a greater overall legal certainty for the given substance. It has an impact on any person or business using, disposing, storing, handling or transposing animal-by-products.

Applicability for Medical Devices, In-vitro diagnostic medical devices & Cosmetics

One the most significant change that the Regulation introduces is the concept of end point in the manufacturing of animal by-products, beyond which the processed products are no longer subject to the requirements of the Regulation, due to the eliminated potential risks via heat or chemical substances. (Article 5 /Rec.22). Consequently, certain finished products such as cosmetics, medical devices and in vitro diagnostic kits are excluded from the scope of Regulation 1069/2009 in this way to reduce operational burdens, e.g. labeling or record-keeping.

The following derived products may be placed on the European market, regulated by certain Community legislation other than that of Regulation 1069/2009 (see Article 33):

  • Cosmetic products as defined in Article 1(1) of Directive 76/768/EEC – See Compliance Page;
  • Active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC – See Compliance Page;
  • Medical devices as defined in Article 1(2)(a) of Directive 93/42/EEC – See Compliance Page;
  • In-vitro diagnostic medical devices as defined in Article 1(2)(b) of Directive 98/79/EC – See Compliance Page;

According to Article 34 importing, collecting animal-by-products for manufacturing the above mentioned devices, their respective Directives should be taken into account. Should not these Directives provide steps to control potential risks deriving from animal-by-products then Regulation 1069/2009 shall be applicable. However, intermediate products intended for the manufacture of medical products, veterinary medicinal products, medical device, active implement medical devices, in vitro diagnostic medical devices or laboratory reagent are subject to the obligations imposed by Regulation in question.

To conclude the above, 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
  • Scope of IVDD 98/79/EC
  • Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,

Since they are not considered as ‘animal by-products not intended for human consumption’. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.


EU Regulation on Animal by-products affects Medical Devices & Cosmetics

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

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
  • Scope of IVDD 98/79/EC
  • Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,

Since they are not considered as “animal by-products not intended for human consumption”. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.

To review the complete analysis under our publication page – Click here;


EU Regulation & CE Marking Workshop in Sao Paulo, BRAZIL

in News

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 Paulo, Brazil concerning the application and revisions of the CE marking as pertaining to the current European Union Directives. This workshop will focus on the CE marking as it applies to Medical Devices, In-Vitro Diagnostic Devices and how the Waste Electrical and Electronic Equipment (WEEE) and the Restriction of Hazardous Substances (RoHS) Directives influence such devices to be placed onto the European Market.

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How are Products That are Considered Both Medicinal and Cosmetic Classified?

in Medical Device Compliance - FAQs, News

Summary of the Guidance Document:

The “Guidance Document of the Demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83 as agreed between the Commission Services and the Competent Authorities of the EU Member States” document attempts to provide guidance for the classification of products that may simultaneously fulfill the definition of a cosmetic product (as per the 76/768 Directive) as well as the definition of a medicinal product (as per the 2001/83 Directive).

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EU Market, Timeline & Harmonization

in Medical Device Compliance - FAQs, News

CE marking directives

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)

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Italy Registration Update: Class I Medical Devices

in Industry News Medical Devices, News

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 Health Database. It has been confirmed by the Italian Ministry of Health that manufacturers of Class I Medical Devices with an EC Rep established outside of Italy are not obligated to complete such registration.

CRITICAL Update

While this may seem to be an improvement to the current system for Class I manufacturers, it is not necessarily in their best interest. If a manufacturer decides not to register its Class I device, the device is only authorized to be sold in the private sector, thus drastically reducing market potential and sales. With Class I registration, devices may be sold to both the public and private sectors.

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Commission Decision on the European Databank on Medical Devices

in Industry News Medical Devices, News

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 2012) to enter information on manufacturers, ARs and devices for all medical devices currently on the market and those going on until 1st May 2011.

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Obelis International Offices Convention

in News

Obelis has launched its new International Offices and will be hosting EROMED at its home offices in Brussels, Belgium.

EROMED is a 2 day workshop exclusively aimed at Obelis International Offices (O.I.O) network – providing regulatory updates, knowledge & expertise and promoting Obelis European Authorized Representative Center (O.E.A.R.C.) services in their global markets.

The Workshop is organized by Obelis s.a European Authorized Representative Center & GiDoS s.p.r.l in association with INTERTEK. Presentations will be given by experts in their fields about the latest developments in the European Regulatory framework concerning Medical Devices, In-Vitro Diagnostics, Cosmetic products, and others, with a special emphasis on the recent implementations of the 2007/47/EC, as of March 21st, 2010 (MDD), and the EC 1223/2009, as of November 30th 2009 (Cosmetics).


EROMED workshop in Sao Paulo a Success!

in News

EROMED, 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 company representing the Czech Notified Body ITC in Brazil.

img_event_Euromed Sao Paulo 1 img_event_Euromed Sao Paulo 2

The workshop involved over 40 participants, including a representative of ABIMO, the Brazilian Association of Medical Devices Manufacturers .

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New Guidance on classification has been published

in Industry News Medical Devices, News

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 medical devices”.

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Legal Challenges at time of Non-Renewal of a CE certificate

in Industry News Medical Devices, News

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 conformity with the applicable European regulation. In this case in compliance with the Medical Device Directive.

One of the requirements for upper Class devices (Class IIa, IIb or III) is to obtain a CE certificate issued by a European Notified Body – the CE certificate has a time and activity related validity. Based upon his certificate the manufacturer is allowed to place medical devices in the European market.

What happens if the CE certificate is NOT renewed?

1. Is the manufacturer allowed to place NEW devices on the market?
2. What about the existing devices already on the market? Should the manufacturer recall his devices? What are the manufacturer’s responsibilities?
3. Can the manufacturer change his claim and therefore affix the CE marking based on another Directive?

Obelis Senior Regulatory Expert, Dr. Peter Ruys provides his view on these important questions;

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New Portuguese National Law Transposing the 2007/47/EC announced

in Industry News Medical Devices, News

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 for medical devices (Dir 93/42/CEE and 90/385/CEE) came into force as of March 21st 2010.

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Medical Devices to Comply with the PPE 89/686/EEC

in Industry News Medical Devices, News

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 MDD 93/42/EEC as Class I medical devices AND also with the essential safety requirements of the PPE 89/686/EEC.

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Obelis launches “EROMED” Workshop

in News

EROMED is a 2 day workshop exclusively dedicated to the NEW European regulation imposed by the 2007/47/EC. The Workshop is organized by Obelis s.a European Authorized Representative Center & GiDoS sprl in association with MDC Medical Device Certification GmbH a German Notified Body, the Israeli Chamber of Commerce and the Israeli Export Institute. You will be taught by experts in their fields about the latest developments in the European Regulatory framework concerning Medical Devices in reference to the upcoming implementation deadline of March 21st 2010 by the 2007/47/EC.

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