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Strategic Planning for Regulatory Compliance

Will you wait until your company has an unannounced audit by a Notified Body? Or will you develop a Quality Plan to prepare for these changes? The principles in this article apply to all medical device manufacturers, any device and every new and revised regulatory requirement. The purpose of this article is to illustrate best practices in strategic planning for companies.

This is a brief story about an orthopaedic device manufacturer somewhere near you.

March 21, 2010: The M5 version of the European Medical Device Directive (MDD) went into effect. Your company was relying upon a regulatory consultant to help stay current with the European requirements, but there were no new CE Marked products at that time.

December 4, 2010: Your company received a major nonconformity during an annual surveillance audit by the Notified Body. The nonconformity was specific to your company’s failure to be compliant with the changes in the M5 version of the MDD.

January 2, 2011: You joined the company as the new Regulatory Affairs Manager. You had 45 days to implement corrective actions so that the company could continue to sell implants in Europe.

February 15, 2011: The Notified Body “knocked-down” the major nonconformity to a minor nonconformity. You had until your recertification audit in December to complete the corrective action plan.

September 26, 2012: The European Commission released a proposal for a new Medical Device Regulation.[1] This is the most sweeping change in European medical device regulation since the CE Marking process was first implemented in 1993. The proposed regulations will be debated in the European Parliament and the Council of the European Union during 2013, and the final regulation is expected to come into force sometime in 2014. The top management at your company decided to wait until the regulations are finalized.

October 10, 2012: The third revision of the Code of Conduct for Notified Bodies is finalized. This third revision includes minimum requirements for the frequency of unannounced audits at medical device manufacturers. You were unaware of this change, because you have been focusing your time upon the completion of a 510(k) submission for the US FDA.

December 19, 2012: You completed a Notified Body annual surveillance audit, but the auditor identified a negative trend of complaints about damaged packaging that your company has not yet taken corrective actions to resolve. The auditor also issued a minor nonconformity related to supplier controls for a contract manufacturer that performs contract packaging for your company.

May 14, 2013: Your Notified Body shows up unannounced at your contract manufacturer to perform an audit. You are one of the first companies to be subject to an unannounced audit. This is part of the specific interim measures that Notified Bodies are required to implement in 2013.2 The Notified Body issued a major nonconformity against your company related to the lack of supplier controls. The supplier was not following your company’s documented procedures regarding final inspection of packaging prior to shipment to the contract sterilizer.

The above fictitious story illustrates how companies that do not take a proactive approach to preparing for changes in regulations can be caught unaware. Will you wait until your company has an unannounced audit by a Notified Body? Or will you develop a Quality Plan to prepare for these changes?

Although the most significant regulatory changes on the immediate horizon are specific to CE Marking, the principles in this article are applicable to all medical device manufacturers, any device and every new and revised regulatory requirement. The purpose of this article is to illustrate best practices in strategic planning for companies.

In order to ensure that you are prepared for regulatory changes, I recommend the following step-by-step approach:

  1. Develop systematic processes for gathering information about new and revised regulations.
  2. Perform a gap analysis of your existing policies and procedures against these new and revised regulations in a timely manner.
  3. When needed, initiate Quality Plans for implementing changes in your Quality Management System (QMS) when gaps are significant.
  4. Hire independent regulatory experts to perform internal audits of regulatory compliance (i.e., mock inspections) at least once per year.
  5. Develop qualified back-up personnel for the Management Representative so that someone is prepared to take action (when needed) in absence of the Management Representative.

 

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