Navigation Links
Helping Start-Ups Avoid Slow-Downs
Date:6/28/2012

RESTON, Va., June 28, 2012 /PRNewswire/ -- For U.S.-based medical device start-ups, speed to global markets is often the most pressing concern, but trying to move too fast often leads to preventable mistakes that could take the CE Marking process back to the drawing board, according to healthcare experts at BSI Group America, a leading Notified Body that helps companies comply with the essential regulatory requirements of the European Union.

(Logo: http://photos.prnewswire.com/prnh/20110405/NE77664LOGO)

CE Marking on a product ensures the free movement of the product within the European Free Trade Association and European single market that totals 30 countries, giving manufactures a wealth of global opportunities. The best way to avoid snags in the approval process, says Paul Brooks, SVP for BSI Healthcare Solutions, is to learn from the mistakes made by companies who have previously gone through the process.

"Everyone makes mistakes, but in the medical device industry, a mistake can set a manufacturer back months or years and often millions of dollars," said Brooks. "It's best to learn from others' mistakes and get it right the first time."

To help new medical device companies do just that, Brooks has identified the following seven "rookie mistakes" typically made by medical device start-ups.

  1. Assuming regulatory clearance in the U.S. is a gateway to CE Marking in Europe.
    Medical devices in the EU are governed by one of three Medical Device Directives (MDD, AIMD, IVDD). While going through the FDA's process might help in a manufacturer's ability to present technical data for review, previous FDA regulatory clearance plays no part in the CE Mark certification decision.
  2. Your product does not fit the definition of a medical device in the EU.
    European medical device Directives are very specific about what they consider to be "medical devices." As a result, a product that is defined as a medical device in the U.S. might in Europe be considered a cosmetic or drug or personal protective equipment or food or lab equipment (or something else) that would be reviewed using an entirely different set of standards.
  3. Your subcontractors do not possess appropriate quality certification.
    When a manufacturer obtains parts or service from a third party, that subcontractor must have the appropriate Quality Management System (QMS) certification, or approval may be declined. Subcontractors must have a QMS certificate issued by an EU/EEA Notified Body that is valid for the indicated product or service and location as specified by the manufacturer.
  4. Lack of a risk-appropriate Clinical Evaluation Report (CER).
    Regardless of device classification, all applications must include a risk-appropriate CER conducted by qualified individual(s) evaluating the technology, research methodology, and clinical diagnosis / management of the subject device or equivalent devices. A literature review and predicate device substantial equivalence (similar to what is required in a US 510[k]) may not be sufficient.
  5. Not having or executing an appropriate Post Market Surveillance (PMS) Plan.
    To support CE marking of a device, a manufacturer must present a PMS or Post Market Clinical Follow-up Plan to confirm clinical performance and safety throughout the expected lifetime of the specific device or group of devices. Using a generic PMS procedure would not be sufficient.
  6. Expecting a fast approval of your device-drug combination product.
    In general, device-drug combination products are ruled class III under the MDD and require both a device review by the Notified Body as well as a medicinal consultation with a Competent Authority — a process that typically takes 210 days to complete. Where claims are made that a drug is present but "not liable to act," the manufacturer will often need to demonstrate this through scientific data (i.e. in vitro or in vivo studies).
  7. Submitting a technical file or design dossier that is poorly assembled or incomplete.
    A poorly organized submission wastes time and therefore money while the reviewer struggles to get through it.

Brooks added that there are some mistakes that are less common, but are worthy of an "honorable mention," including:

  • Not justifying the benefit of a 2003/32/EC device (one using animal tissue) over a lower-risk species or synthetic device.
    In Europe (unlike in the U.S.), manufacturers must demonstrate with data that the benefits of using animal tissue outweigh the associated risks relative to lower risk material alternatives.
  • Conformity with Harmonized Standards cannot be demonstrated.
    While the use of European Harmonized Standards is voluntary, a lack of compliance to the standard must be accompanied by a gap analysis or justification of the decision to not conform.

To learn more about what medical device manufacturers need to know and do in order to obtain CE Mark certification for a product, visit www.BSIAmerica.com/Healthcare or call 800-862-4977.

About BSI
BSI (British Standards Institution) is a global organization that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Formed in 1901, BSI was the world's first National Standards Body and a founding member of the International Organization of Standardization (ISO). Over a century later it continues to facilitate business improvement across the globe by helping its clients drive performance, reduce risk and grow sustainably through the adoption of international management systems standards, many of which BSI originated. Famed for its marks of excellence including the instantly recognisable Kitemark®, BSI's influence spans multiple sectors including aerospace, construction, energy, engineering, finance, healthcare, IT and retail. With over 64,000 clients in 147 countries, BSI is an organization whose standards inspire excellence across the globe.  To learn more, please visit www.bsigroup.com.

About BSI Healthcare Solutions
BSI Healthcare's mission is to ensure patient safety while supporting timely access to global medical device technology. We provide thorough, responsive, predictable conformity assessments, evaluations and certifications that are recognized and accepted worldwide. To learn more, please visit www.bsiamerica.com/healthcare.

Media Contact
Shereen Abuzobaa
VP Marketing & Training, BSI Group America Inc.
703-464-1931


'/>"/>
SOURCE BSI Group America Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Multiple Sclerosis Association of Americas MRI Institute Marks 10 Years of Helping Individuals with Multiple Sclerosis Obtain MRIs
2. NuMe Health Completes $1.5 Million Series A Financing To Advance Its First Cobiotic™ Aimed At Helping Prediabetics Maintain Healthy Blood Glucose Levels
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... 4, 2016  Omnicell, Inc. (NASDAQ: OMCL ), a ... healthcare systems, today announced results for its fiscal year ... --> --> GAAP results: Revenue for ... $5.1 million or 4.1% from the third quarter of ... fourth quarter of 2014. Revenue for the year ended ...
(Date:2/4/2016)... 2016  Aethlon Medical, Inc. (Nasdaq: AEMD ... to treat life-threatening diseases, today announced results for ... 31, 2015. --> ... in our last quarterly call, we strategically advanced ... objective to establish the Aethlon Hemopurifier® as a ...
(Date:2/4/2016)... 4, 2016  AMRI (NASDAQ:  AMRI) today announced that ... and President of Pfizer Global Supply, has been elected to ... 2016. In addition, the Company announced that Mr. Gabe ... since 2010, has retired from the AMRI Board of Directors ... other business ventures.  William S. Marth , ...
Breaking Medicine Technology:
(Date:2/7/2016)... Texas (PRWEB) , ... February 07, 2016 , ... ... new MyDecision™ program. MyDecision™ empowers employers and organizations with the tools and information ... MyDecision™ combines three elements to cut the cost of providing employee healthcare benefits ...
(Date:2/6/2016)... ... February 06, 2016 , ... ... ADVISORY: 5000 PERIOPERATIVE NURSES EXPECTED AT AORN SURGICAL CONFERENCE & EXPO , ... the world with an estimated 5000 perioperative nurses in attendance to study ...
(Date:2/6/2016)... ... ... With the FCPX LUT: Summer pack from Pixel Film Studios, ... is a Lookup Table that contains a mathematical formula for modifying an image. The ... manipulating each pixel, LUT's can change each color range differently, it gives the user ...
(Date:2/6/2016)... , ... February 06, 2016 , ... ... of eating disorder treatment helps to reduce the frequency and level of relapse. ... Recovery Phase: Re-Establishing Healthy Identity and Purpose,” will explore the critical tasks of ...
(Date:2/5/2016)... ... February 05, 2016 , ... Love is in the air ... variety of colors, assortments and packaging. This staple for Valentine’s Day is a must-have, ... , For Valentine’s Day, not only are long-stem roses available, but also other ...
Breaking Medicine News(10 mins):