European Commission Addresses Notified Body Abuse

Medical device makers don’t need to retest to voluntary standards, says EC

Some European Commission notified bodies have been forcing a position that a medical device must conform to the latest technical standards to meet the European legal requirement for “state of the art.” As a result, some manufacturers have been pressed into paying tens of thousands of dollars to retest their products or risk losing their CE Mark.

The European Commission has received a number of complaints from industry, which has led to an investigation and rebuke of the practice, where a notified body issues a legal nonconformity against the Medical Device Directive 93/42/EEC to a company that has not applied the latest voluntary standards. Some evidence of this practice was reviewed by the European Commission along with widely published documents by NB-MED, an organization representing notified body interests in Europe.

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Certification abuses

Dear Mr. Ramaley, I already commented on the real value of accredited certification, therefore on the roles and performance of Accreditation Bodies. You point the finger on Notified Bodies, that most often make business as Certification Bodies, or Registrars, too. Yes, THEY MAKE BUSINESS; and they make business just the same as the more or less international Organizations that publish Standards. Surely Industry is not happy when required to spend thousands dollars because the Standard Publisher has changed a couple of lines of its product - see the cases ISO 9001:1994, the ISO 9001:2008 versus the 2000 edition , and ISO 14001:2004 versus the 1996 edition. The fact that ISO declare that their Standards will be revised every five years, is all but justifiable, both in technological and economical terms: a Standard has to be modified when there is consensus on the need that it has to be modified. But, as this Planet keeps revolving, there's all evidence that its inhabitants who have enough power push others for filling their own pockets. The others cannot but resist, digging deeper trenches. Thank you.