Medical Device Notified Body meeting - April 2012: Brussels

#1
Apparently there has just been a meeting of the Notified Bodies.
April 2012: Brussels, Medical Device Notified Body Meeting

The first Medical Device Notified Body meeting of 2012 took place last week in Brussels. Notified Bodies, the European Commission, Authorities, and Industry representatives met to discuss the recently highlighted concerns with specific CE Marked devices in Europe (i.e. PIP breast implants, metal on metal joints, and certain meshes).

The effectiveness of current European regulations and the full effectiveness of Notified Bodies has been under review. During the meeting, the European Commission strongly encouraged Notified Bodies to adopt the Code of Conduct, originally authored by five respected Notified Bodies, including BSI. To date, twelve of over seventy Notified Bodies, have now adopted the Code of Conduct.

Notified Bodies are also being advised to use their existing authority to conduct more unannounced inspection visits to manufacturers, conduct product sampling, witness device testing during audits, and perform market surveillance. Guidance is expected to be developed and issued to Notified Bodies on these practices soon. In order to support the recommendations, leading Notified Bodies have agreed to review, improve and confirm implementation of the Code of Conduct as required to immediately help address the concerns of stakeholders and the European Commission.

In other discussions, the issues around ISO 13485, ISO 14971, and EU Harmonization appear to have been resolved. Agreement to both standards being reconfirmed as Harmonized under the European regulations has taken place and will take effect by lifting the EC formal objections to their harmonization. The amendment of the standards to include revised and more specific Annex Zs to addressed doubts regarding the suitability of both standards to provide the presumption of compliance with the relevant requirements of the medical device directives.
That was from a news shot from BSi. I added the bold to highlight what I think is the most significant part.
 
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phloQS

#3
Re: Medical Device Notified Body meeting

Hi to all,

We just had our surveillance audit for ISO 13485. We had the discussion of unannounced audits with our lead auditor. His opinion was, that unanounced auits would not bring much effort as they are practically not feasible. A company like ours (400+ employers) is a small one and we need two days for an audit. What should big companies do (greater 1000 employees)? The NBs also do not have the manpower to conduct these audits. As the auditor told us there shall be a change in RL 93/42 which shall demand such unannounced audit once a year. I would say this will be implossible. The volume of audits would be doubled for the NBs. Who shall conduct these audits?

Regards

phloQS
 

pkost

Trusted Information Resource
#4
Re: Medical Device Notified Body meeting

The notified bodies are already pushed with the 2007 changes which clarified the ongoing review of technical files. There is another thread discussing this and how, when, if it is going to be done - Files here certainly haven't been reviewed and another company I'm aware of is only just sending them after they received a request the other month.

In the current state it is unfeasible to carry out unannounced visits on all companies. The burden would be immense; are risk based approach would be far more reasonable, high risk devices would attract review. Also perhaps in collaboration with CA's identify companies who are reporting significantly less than other companies selling similar products and companies that are reporting higher than trends.

Ultimaltely, if there is a will there is a way - notified bodies will get bigger and the cost will be passed on to the unwilling manufacturer; the only factor is the lag from training staff to carry out the reviews
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Medical Device Notified Body meeting

The notified bodies are already pushed with the 2007 changes which clarified the ongoing review of technical files. There is another thread discussing this and how, when, if it is going to be done - Files here certainly haven't been reviewed and another company I'm aware of is only just sending them after they received a request the other month.

In the current state it is unfeasible to carry out unannounced visits on all companies. The burden would be immense; are risk based approach would be far more reasonable, high risk devices would attract review. Also perhaps in collaboration with CA's identify companies who are reporting significantly less than other companies selling similar products and companies that are reporting higher than trends.

Ultimaltely, if there is a will there is a way - notified bodies will get bigger and the cost will be passed on to the unwilling manufacturer; the only factor is the lag from training staff to carry out the reviews
So your prediction is, in simple words, that the entire auditable manufacturers community will pay the misbehaviour price for a few defiant manufacturers and non-vigilant NBs? :lol:
 

Marcelo

Inactive Registered Visitor
#6
So your prediction is, in simple words, that the entire auditable manufacturers community will pay the misbehaviour price for a few defiant manufacturers and non-vigilant NBs?
Well, this has happened (at least to the mammary implants manufacturers and importers) in Brazil due to the PIP problem :p
 
G

Gert Sorensen

#7
Re: Medical Device Notified Body meeting

So your prediction is, in simple words, that the entire auditable manufacturers community will pay the misbehaviour price for a few defiant manufacturers and non-vigilant NBs? :lol:
You might argue that we all do already pay for their misbehaviour. We pay with increased scrutiny by regulatory institutions, and a general bad-will towards the medical device industry. :(
 

pkost

Trusted Information Resource
#8
Well if it is not the manufacturer that pays for the regulatory costs, then who is it? Should it be funded by the government/tax payers? I don't think that would be a popular choice for the decision makers these days!

The current trend for the regulations is for them to become more burdensome, this is apparent in a number of ways:

1. Device classification changes...how many have you seen go down?
2. 2007 clarification of clinical evaluation requirements
3. 2007 clarification of ongoing review of technical files by NB

Certainly there have been ways to introduce efficiencies and reduced burdens, such as EUDAMED and electronic IFU's, but the overall trend is for regulatory burden to increase.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Well if it is not the manufacturer that pays for the regulatory costs, then who is it? Should it be funded by the government/tax payers? I don't think that would be a popular choice for the decision makers these days!

The current trend for the regulations is for them to become more burdensome, this is apparent in a number of ways:

1. Device classification changes...how many have you seen go down?
2. 2007 clarification of clinical evaluation requirements
3. 2007 clarification of ongoing review of technical files by NB

Certainly there have been ways to introduce efficiencies and reduced burdens, such as EUDAMED and electronic IFU's, but the overall trend is for regulatory burden to increase.
Well, I may be naive, but in an ideal world I'd expect more scrutiny where it can actually do good, and clever utilization of resources. Tighter scrutiny across the board is neither, IMO :(

Going from no-unannounced-auditing-at-all to unannounced-auditing-for-all-every-year looks to me like a panicked reaction or an attempt to appease the lay public (or both).

Probably just :deadhorse:

:frust:
 

pkost

Trusted Information Resource
#10
Between your naivity and my pessimism....




Certainly a risk based approach would be beneficial. the competent authorities could base if off already avaliable information...
1. Device classifcations the company makes
2. Number of incident reports receive.....does it trend high (in-effective) or low (not reporting or hiding information)
 
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