CE Marking Medical Devices Regulations

CE Marking Medical Device Boundary Issues – Is it a Medical Device

Manufacturers of Class I (sterile / measuring) devices IIa, IIb and III devices shall be certified with respect to the CE marking Directive 93/42/EEC by a notified body before using the CE mark and place products on the market.

To allow your organization to achieve certification on the CE, SGS is Notified Body 0120 in accordance with Directive 93/42/EEC for all devices including combination drug / medical device and associated directives 2003/32/EC (animal tissue), 2005/50/EC (total joint replacement) and 2007/47/EC (as amended). An audit of SGS successfully ensure the compliance of your products and certification 93/42/EEC.

Our global network of local offices ensures that wherever you are your business or industrial activity, certification 93/42/EC can be obtained effectively and efficiently.

The options for certification under this Directive include Annex II, V and VI include audits of the site and / or assessment of technical documentation. Our site audit usually assess compliance with both ISO 13485:2003 and with Directive 93/42/EEC.

The accreditation UKAS (United Kingdom Accreditation Service - accrediting agency of the United Kingdom) and close links with the European Commission and the competent authorities make us the natural partner to meet your needs for CE certification. The collaboration with SGS gives you access to the expertise of experts, a global network of controllers and the opportunity to combine the CE marking with our wide range of other legal certifications in a single audit.

CE marking and ability to sell your medical devices in Europe with 93/42/EEC certification of SGS UK.

Send us an email

PharmaLogika Canadian Good Manufacturing Practices: Pharmaceutical, Biotechnology, and Medical Device Regulations and Guidance Concise Reference
Book (PharmaLogika)
2013-03-20 12:19:34 by flaveur

"Obamacare" ..jobs destroyed in NY, WI, MA, etc.

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

2013-03-20 12:20:55 by flaveur

Um, it's actual closings and layoffs. Hello?

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

You might also like:

Make Money on Blogger with Google AdSense
Make Money on Blogger with Google AdSense
Medical Device Recruiter "blows whistle" on ST. JUDE Medical
Medical Device Recruiter "blows whistle" on ST. JUDE Medical
My Naked Secret: Seeing a Woman
My Naked Secret: Seeing a Woman

Veteran voices caution for women in the military  — Press Pubs
She signed up to become a medic because she had a bit of prior medical training as a lifeguard and it sounded more exciting than other options such as working in a kitchen or an office. After training she was sent to a small ..

Fueling the entrepreneurial spirit  — Harvard Gazette
HMS student Marc Succi, who recently founded a medical device company, said the entrepreneurial spirit is also alive and well among the student body at the Medical School.

Prince Edward Island.(Legislative Reports): An article from: Canadian Parliamentary Review
Book (Canadian Parliamentary Association)

Related posts:

  • Avatar Johnny Weissmuller, Jr. If you are an inventor with a new med device, how can you test it in a hospital?
    Jun 19, 2011 by Johnny Weissmuller, Jr. | Posted in Other - Diseases

    How you do it to test it with real patients? In steps according you. From a list to 1 to 5 my med device is the most simple device there, plus it uses no rays, waves, etc, just a simple material.

    • Man from Atlantis, The answer by “N” is correct. However, the process of medical device approval and certification is extremely lengthy – sometimes more so than that of drug approval. If your question is genuinely asked for your own invention of a medical device, (Unless you are a ‘company’ and have financial backing, this will be a most difficult procedure), you would be advised to obtain an overview of FDA requirements of the New Product Design Process. Medical devices are regulated in the United States by the Centre for Devices and Radiological Health (CDRH) of the FDA. Studies involving non-CE …

  • Avatar venkat_adv9 Why there is CE mark is inscribed on electronic goods?
    May 26, 2007 by venkat_adv9 | Posted in Other - Electronics

    We find CE mark is inscribed on cell phone chargers? Computer accesories and many other electronic goods. Is there any abbreviation for CE?

    • The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. The letters CE are an abbreviation of Conformité Européenne, French for European conformity. The CE mark must be affixed to a product if it falls under the scope of the approx. 20 so called New Approach Directives. Without the CE marking, and thus without complying with the provisions of the Directives, the product may not be placed in the market or put into service in the fifteen member states of the European Union and …