The day before the European Parliament was scheduled to vote on adopting a more FDA-style method of medical device regulation, the central European consumer organization issued a video of medical device horror story testimonials, particularly relating to breast implants. This has not helped industry to fight to avoid radical changes.
We (industry) all know that the PIP implant scandal relate to a manufacturer’s fraudulent use of materials, nothing about the EU device regulations but this consumer group believes that more centralized regulation is needed. If consumer groups get their way we could be moving away from the current system, which they criticize for allowing device companies to shop around for the most lenient regulatory body, to the direction of the US FDA.
All of the following points should be considered in relation to the new legislation:
a). Manufacturers should review their control of all critical subcontractors and suppliers (including OEMs if the manufacturer is own brand labelling). Care must be taken to ensure that no legal responsibilities have been delegated and that control is adequate and risk based.
b). Manufacturers should ensure that they have good systems for informing their Notified Body of changes to product ranges, quality systems, critical suppliers and the design of high-risk devices.
c). Manufacturers should ensure that there are written procedures describing processes which will ensure compliance to regulatory requirements. This would include compilation and approval of technical documentation, EC declarations of conformity, vigilance, and determination of class (etc.).
d). Manufacturers should ensure that they are aware of all relevant EU Commission documents including MEDDEVs and classification decisions and that the requirements are incorporated into the QMS and technical documentation.
e). Manufacturers urgently need written procedures for managing unannounced audits, although these are not a requirement to be audited.
f). Manufacturers should ensure that all technical documentation has been updated in line with current device design and manufacturing practice.
g). It is recommended that a check of production against technical documentation and a traceability audit be incorporated into the internal audit process.
h). Manufacturers should make a judgement whether their Notified Body is likely to find compliance with the new requirements difficult because of limited resources, low technical competence or low prices, and consider moving to a stronger Notified Body.
i). Manufacturers should be ready for all the new expectations and unannounced audits from the beginning of 2014.
j). Best practice for manufacturers would be to immediately review the Recommendation document and undertake an internal audit/gap review of processes and technical documentation to identify any areas of weakness and then to implement an improvement plan before the first Notified Body audit in 2014.
Manufacturers who have been implementing best practice, following MEDDEV guidance and ensuring that classification and borderline decisions have been implemented have little to do other than institute a procedure to manage unannounced audits. However manufacturers who have fallen behind current best practice or who have chosen a lenient or incompetent Notified Body will have to review and improve processes and documentation or expect significant non conformities.
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