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Archive: News and Views 2006 July

 

Content:

  • 11 Year Anniversary

  • Regulatory Updates Directive Update

    • Vigilance Guideline Update

    • Standard Update

  • Classification Update

  • New MDSS Address

  • MDSS, the only Authorized Representative certified to EN ISO 13485: 2003

  • Logistics and Distribution in Europe

 

Dear valued Client,

July 2006

11 Year Anniversary
You may ask why celebrate the eleventh year and not the tenth year anniversary. This is actually a good question. We simply did not find the time to do so. Therefore, we thought 11 years is also a good number. We want to celebrate with you, our clients, who helped us to be the successful business we are today. Our special for our clients are free seminars. The main topics are going to be the updates of the MDD and the Vigilance guideline. That the MDD is being updated is known in the industry but the vigilance guideline is also in its final stages of endorsement and will bring some significant changes to the European vigilance process which should be taken into consideration in your quality system. Other topics are Labeling Compliance, Product Notification Process and Competent Authority Interventions. Please go to our website to find more details www.mdss.com


Regulatory Updates

 

Directive Update

There is no news regarding the Medical Devices Directive since our last newsletter. The review is ongoing. The next step for the commission is to bring the text to the European parliament. In there the revision has to go through the legal proceedings with readings and voting. A very optimistic timeline for its release is early 2007 but it may take significantly longer.

Further details will be given during the seminar series and in future newsletters.


Vigilance Guideline Update

A subgroup of the Medical Device Expert Group (MDEG) worked for quite some time on the update of the Vigilance Guideline MEDDEV 2.12-1 rev. 4 from April 2001. This guideline will have to be endorsed by the MDEG itself to be accepted EU-wide. The subgroup consisted of members of the industry associations and various competent authorities (CA). One goal was to keep the European document in line with the Global Harmonization Task Force (GHTF) document. This was not possible in all areas due to CA intervention. As soon as the new guideline is released it should be used when complying with the European post marketing activities. There are significant improvements to the document which should be taken into consideration in your quality system. The areas of improvements are:

 

* Definition section has been implemented
* Notification of recall has been clarified
* Incident, near incident and timeline clarification
* Information exchange has been improved
* The concept of use error was introduced

 

Further details will be provided during the seminar series and in future newsletters. MDSS will be happy to review your vigilance procedures to ensure the compliance.


Standard Update

The standard EN ISO 13485:2003 replaces EN ISO 13485:2000 on July 31, 2006. This deadline is the end of the transition period. All companies that utilize the EN ISO 13485 for compliance for CE marking are in the need to update the certification. Any future audit should be conducted to the EN ISO 13485:2003 standard. We would assume that your notified body already informed you since it is a major part of their business.


Classification Update

Total Joint Replacements have been reclassified to risk class III. The reclassification was achieved via the European Directive 2005/50/EC which was published on the August 11, 2005. Article 3 of the directive clearly outlines what needs to be done and when. Manufacturers have time to update their files until 2009 respectively 2010. Please refer to the original document.


New MDSS Address

MDSS is proud to announce that it will move to a new permanent address. The building we are going to occupy will now belong to MDSS. The address is the most important aspect of the AR. We are fully aware of this and therefore we made provisions to keep the old address valid until at least 2012 and even longer if a client will have difficulties to change his labeling. Nevertheless, we would like to ask you to update with the next label and instructions for use revision the MDSS address. This is as well a good opportunity to utilize the AR symbol from EN 980. Please see below the example on how to disclose the AR.

MDSS, the only Authorized Representative certified to EN ISO 13485: 2003

MDSS was the first AR to be certified to EN ISO 9002: 1996 and EN 46002. We updated our system to the new EN ISO 9001: 2000 and the EN 13485: 2000. Now we are certified to the new EN ISO 13485: 2003. According to our knowledge we are the only AR achieving this certification in the interest of our clients. The certificate was issued by TUV Product Service the market leader. Enclosed is a copy of the certificate for your vendor file. A quality system certificate from a reputable notified body with the applicable quality system standard should as well be acceptable to your notified body as vendor approval.

Logistics and Distribution in Europe

MDSS as your AR in all matters of European regulatory affairs has been approached by clients to offer solutions for distribution. This is a different business and MDSS should not be involved in the distribution for very valid reasons. For example would other distributors of yours accept the prominent position of MDSS on your label and be in competition? It is very difficult for a distributor to make the right independent vigilance decisions! This could compromise your responsibility for vigilanc.

Next to our office in Atlanta a logistics and distribution company is setting up their US subsidiary for the support of US companies for the logistics and distribution of products in Europe. We would like to recommend their service and also give them an opportunity to present themselves here.

 

Realize your success

From Prestige Promotion GmbH

Selling products within the European Union can be difficult at best. Although EU countries are making attempts to become more standardized, Europe consists of 25 different countries, nearly each with their own language, customs and additional local regulations next to the CE mark. Therefore, a secondary packaging process for health care, medical devices, pharmaceutical or cosmetic products is often necessary in order to meet all applicable laws and guidelines or simply to distinguish markets.

Helping medical devices, pharmaceutical and cosmetic companies to overcome these obstacles has been Prestige Promotion’s main goal for over 12 years. Prestige Promotion is certified to pack and distribute medical devices, pharmaceuticals throughout Europe, according to the Good Manufacturing Practice (GMP) standards, the German Pharmaceutical Act (§ 13 AMG) and soon EN ISO 13485:2003. This guarantees that your products will exceed each and every standard necessary for success in the European market.

Prestige Promotion provides a full range of customized logistic services, from secondary packaging to storage, order compilation and distribution. The company’s main strength is flexibility – it offers unique solutions based on the individual needs and requirements of their clients. With more than 200 employees and a 5,600 m² facility ground located in the heart of Europe, Prestige Promotion is capable to meet all packaging and storage needs.

With an outsourcing partner like Prestige Promotion you can keep your focus on your core business, while being assured that your products are in good hands.

 

Realize your success within the European market.
For further information see www.prestige-promotion.net
or call Margit Stüber +49 6027-46 14 24

 

German Office
Prestige Promotion GmbH
Lindigstr. 6
D-63801 Kleinostheim

Tel. +49 6027 461 424
Fax +49 6027 461 450

 

US Office
Prestige Promotion
530 Means St.
Suite 120
Atlanta, GA 30318

Tel. 404 586-6839
Fax. 404-586-6820

Certainly if you have any questions or would like to have further clarification, to any of the above do not hesitate to contact us.

Yours sincerely
Ludger Möller
President
MDSS



Abbreviations Used
MDD - Medical Device Directive
IVD - In Vitro Medical Device Directive
EN - European Norm (harmonized standard if published in the official Journal of the EU)
EU - European Union
ISO - International Standard Organization
AR - Authorized Representative
MDEG - Medical Devices Expert Group
GHTF - Global Harmonization Task Force
MDSS - Medical Device Safety Service GmbH
CA - Competent Authorities

 

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