What if you scheduled an audit and nobody came?

If you think you're having a bad day at the office, check out this cautionary tale. It's a true story recounted by Monir El Azzouzi, Quality and Regulatory Compliance Manager at Johnson & Johnson in Zug, Switzerland, on the France Dispositif Medical page on LinkedIn. The names have been changed to protect the innocent and not-so-innocent.

Our hero, let's call him Carl, has been put in charge of getting his company's quality systems up to snuff so that it can apply for ISO 13485 certification and place the CE mark on a new product and sell it in member states of the European Union and other countries that recognize the seal.

Carl spent six months getting the systems in order and compiling the paperwork, and made an appointment to have auditors come to the office with a two-month lead time. Just before the audit, subject matter experts from the company's headquarters as well as staff from various departments from the organization's far-flung locations congregated at the site. The day before the scheduled audit, everyone is gathered in the conference room going over the documents one last time. They are feeling quite confident. Then the phone rings. It's the auditing organization calling to tell Carl that the auditor is sick and won't be able to come out. No other auditors are available, so the meeting will have to be rescheduled. As he hangs up, an assistant who is making the lunch arrangements for tomorrow's audit asks how many people will be in the meeting. Ashen-faced, Carl announces to everyone that the meeting has been cancelled.

So far, so bad. The audit needs to happen, however, and Carl reschedules the meeting for two months later, but he stresses to the auditor that he will need a formal confirmation. Several weeks go by and, despite repeated phone calls, Carl is unable to get a firm commitment from the auditor. The week before the meeting, still without a confirmation, Carl takes a preemptive measure and cancels it before everyone has made travel arrangements. Meanwhile, the timeframe for bringing the product to market has been seriously compromised.

This is a scenario that may play out to an alarming degree in the years ahead for medical device manufacturers seeking to place products in the EU marketplace. Why? It's the law of unintended consequences.

The European Commission has tightened requirements for Notified Bodies, third-party conformity assessment bodies that verify that a company has met the standards and regulations in force, allowing it to place a CE mark on its products. The Pip implant scandal—a French maker of breast implants fraudulently used industrial rather than medical-grade silicone for several years unbeknownst to its Notified Body—and dubious business practices on the part of some of the assessment bodies forced the Commission to take action. The toughened requirements, however, have led to a reduction in the number of Notified Bodies in operation.

"The rules to become a Notified Body have changed," writes El Azzouzi on the LinkedIn page, such that fewer of them are able to comply. According to Medídee, a French company that provides regulatory and clinical affairs quality management services, the number of Notified Bodies operating in the medical space has been in steady decline since 2012, and it projects that there will be approximately 50 in 2015 compared with the 70 or so Notified Bodies that had their shingle out in 2014. By 2016, that number will drop to around 40. Carl, it seems, is the canary in the coal mine.

Eventually, Carl's company was successfully audited, but the story does not end there. He still had to wait another three months for the Notified Body's board to review the documents and issue a final approval. This is another new requirement.

We are not against improving the regulatory process, writes El Azzouzi, but we think that a strategy should have been put in place to prevent problems like this from arising. "A signal should have been put in place to get more resources to Notified Bodies that are supporting healthcare companies."

He also has some sage advice for anyone who may be under- or unemployed: "If you are looking for a job, train to be an auditor. Notified Bodies are looking for you, as they have no choice, and healthcare companies need you so that they can sell their products. Please help our entities to get certified," writes El Azzouzi.

— Norbert Sparrow

Norbert Sparrow is Senior Editor at PlasticsToday. Follow him on twitter @norbertcsparrow and Google+.