Something Funny Happened on the way to the Notified Body
By: Yvonne Halpaus QNET LLC.
Notified Bodies are the only CE marking approval bodies recognized by the European Commission. In all cases Notified Bodies are "notified" (nominated) for the CE marking approval of medium and high risk devices. A Notified Body is independent and recognized by the Government of its Member State and nominated to the European Commission in Brussels. Some Member States nominate Notified Bodies without ensuring compliance with the following standards: EN 45001 (Test laboratories) and EN 45011 (Product certification) and EN 45012 (Certification Quality Systems), others go as far as appointing an Accreditation Authority to audit Notified Bodies against EN45001 and EN 45011.
With the notable exception of some EC member States few Notified Bodies have been accredited to all three standards. Sometimes poor coordination and control of some agencies have permitted differing interpretations to suit commercial interests. Solutions have started to emerge with the creation of meeting groups of Notified Bodies, but differences continue to affect manufacturers. Not all Notified Bodies are represented in these meetings.
This report chronicles the Notified Body selection we performed on behalf of a manufacturer of Risk Class I sterile medical devices. A subcontractor certified by a Notified Body actually performs the sterilization.
Getting Started-- Knowing that early Notified Body selection is important in the overall ce-marking process, we decided to contact a representative cross-section of Notified Bodies – some with offices in the US, some overseas. As the data accumulated, we felt comfortable that we had solicited a representative set.
Issues-- A number surfaced almost immediately--some of them attitudinal--most because US offices are constantly in a frustrating waiting mode for the final proposal to arrive from their European Headquarters.
*
Initial Contact-- Five Notified Bodies were contacted by telephone in the US and Europe. We emphasized that we wanted a CE-proposal concerned with the sterilization aspects only. We clarified that the client did not have an ISO 9000 Quality Assurance System at this time.
*
Responses-- All of those with whom there was a conversation sent us a proposal in the end-- most of them were delayed by several weeks and when they arrived they included services ( ISO 9000 certification) not required or were too general. We went back and asked each one of them to correct this situation. In the end this lowered our client’s fees substantially (40%). Only two Notified Bodies submitted proposals in accordance with the definition of the scope.
Follow-up -- All of them needed many follow up calls to produce a proposal. (does not give one a warm feeling).
Complications by Notified Body:
Notified Body #1 - Their entire office staff was on vacation and we needed to wait for the return of at least one person who was authorized to process a proposal, duration about two weeks. When the proposal arrived, its scope far exceeded the requirements outlined in the Medical Device Directive and was therefore too expensive. We contacted them with this message and asked them to re-quote, they refused, and no further consideration was given this Notified Body.
Notified Body #2 - Send us a proposal within a reasonable period of time. We made them aware that their proposal exceeded the "scope" as required under the MDD. They advised that if they became the Notified Body of choice and if the client was willing the sign a contract, only then would the correct scope be considered and changes be made.
Notified Body #3 - Send us a quote after many follow up calls and included services for preparation of technical file documentation, although we had explained that this had already been done. The proposal lacked any information about annual surveillance. They were geographically closest to the client, which would have kept travel expenses to a minimum. They worked hard on this proposal but in the end they were unable to agree on the scope of the audit with their European Headquarters. At one point their European office demanded that only an auditor from their office could perform Annex IV batch audits. The Medical Device Directive clearly states that Annex IV may not be used for sterilization audits!! When we pointed this out they decided to withdraw their proposal.
Notified Body #4 - When their European office finally responded they provided one of the best proposals including accurate scope. Their auditors travel from inside the USA.
Notified Body #5 - new to the USA, finally responded cautiously.
Comparative Analysis of five Notified Body (NB) Proposals:
|
Proposal |
NB #1 |
NB #2 |
NB #3 |
NB #4 |
NB #5 |
|
Initial |
Surveillance |
Costs |
|
|
|
|
Off site document review
|
$3,000
|
$ 500 |
withdrawn
|
-0- |
-0- |
|
QS Assessment
|
$1,500 |
$2,000
|
|
$3,863 |
$4,000
Estimated |
|
Preparation & reporting |
$1,500 |
$1,000 |
|
-0- |
-0- |
|
Certification cost |
$1,000 |
$1,250 |
|
$1,500 |
-0- |
|
Travel + expenses
Auditors location |
cost + $75/hr
USA |
cost
USA |
|
cost
USA |
cost
Europe |
|
CE agreement |
-0- |
$1,000 |
|
-0- |
-0- |
|
Corrective action
if applicable |
Not quoted |
$1,500/day |
|
$1,545/day |
Not quoted |
|
Annual |
Surveillance |
Costs: |
|
|
|
|
On-site audit |
$1,500 |
$2,250 |
|
$1,545 |
|
|
Off-site prep & reporting |
$1,500 |
-0- |
|
-0- |
|
|
Travel + expense |
cost & $75/hr |
cost |
|
cost |
cost |
|
CE agreement costs |
$800/year |
$1,000/year |
|
$1,000 |
|
|
Proposal expires |
3 weeks |
30 days |
|
30 days |
unknown |
| |
|
|
|
|
|
|
Total 3 year period
(excludes travel) |
$14,600 |
$12,250 |
|
$10,452 |
Incomplete |
|
% |
140% |
117% |
|
100% |
|
DON’T BE CONFUSED: a Certification Body is not always a Notified Body; and Bodies with certification services are even more commercially focused organizations who offer quality marks or product approval and accreditation of quality systems. Certification Bodies are not recognized by the European Commission as Notified Bodies for assessments of products to the European Directives.
BACK
|