SGS Notified Body presented a very interesting Webinar on November 13th (some of you may have been joining in) and this presentation was repeated again during the MEDICA show in Düsseldorf.
The story remains unchanged with Notified Bodies making it very clear that from January 2014 the audit processes will be changing for all manufacturers and distributors who use an EU Notified Body to issue a CE certificate.
This is VERY significant for clients who use Notified Bodies and these changes must be understood
- Unannounced audits (similar to that for the food industry) will be mandatory for all Notified Body CE certified manufacturers and these manufacturers’ significant sub-contractors.
- Such unannounced audits will be once every 3 years by 2 auditors from 8.30 am, for one day. They may be more frequent for high risk devices and if a significant subcontractor makes the whole device the unannounced audits could also be more frequent.
- A “responsible person” must always be available.
- If the facility is not operating, or closed, or entry refused, then the client has to still pay an audit fee and get a major non-conformity. Hence Notified Body must be told of periods of inactivity when audits cannot be made. This must be specified in the manufacturer’s contract with the Notified Body.
- For unannounced audits of 3rd party suppliers / OEMs there may be an opportunity for companies to notify beforehand when operations will be running, or facilities open.
- There needs to be in the contract between the manufacturer and their supplier / OEM to allow unannounced audits to take place.
- The primary site audited will be the one with the name and address on the device label; i.e. the company site responsible for legal activities, even own-branders, who subsequently will have their OEM audited.
- Lack of competence or awareness of regulations will be non-conformity.
- Risk management to EN 14971: 2012 will always be required.
- Clinical data must be complete to MEDDEV 2.7.1. Notified Bodies are now required to employ qualified clinicians or equivalent to review and approve data.
- The EU MEDDEV guidance documents (http://meddev.info/) will all be regarded now as law, not just guidance. All manufacturers will be expected to have knowledge of MEDDEVS
- Post market surveillance records will be inspected, and they will look for feedback from users/patients as well as distributors, so a manufacturer can no longer rely on distributors for handling reports.
- Technical files must cover all variants and device family members and this must be clear within the
- documents. All technical documents must be up-to-date, a 2-3 year review may not be acceptable when known changes have been announced. (e.g. referring to up-issued standards)
- Device must be shown to have a “medical purpose” as per the definitions of medical devices.
- Device designs must show to be “state-of-the-art”, i.e. using modern technology and/or be the subject of continuous design improvement.
- Notified Bodies expect the fee to increase by 20-50%, and Notified Bodies are unlikely to give fixed price contracts in the future.
- Some Notified Bodies will lose their approval to certify to the Medical Devices Directives. Manufacturers can check the NANDO web-site that gives latest Notified Body news and for any of these organisations that has been de-designated for medical devices. If your Notified Body looses it medical device designation you have to find a new one ASAP. http://ec.europa.eu/enterprise/newapproach/nando/
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