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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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