EU reaches agreement on new medical device and IVD regulationsEU reaches agreement on new medical device and IVD regulations

It seems like the drafting of the new European Union (EU) regulations for medical devices and in vitro diagnostics (IVDs) have been going on for most of my adult life. I remember a few years ago Erik Vollebregt, founding partner of the Netherlands-based life sciences law firm Axon Lawyers, likening the process to the construction of Antoni Gaudi’s magnificent cathedral in Barcelona. Groundbreaking of the Sagrada Familia began in the 1880s, and it remains a work in progress to this day. The cathedral is scheduled for completion in 2026, one hundred years after Gaudi’s death. These are exaggerations to be sure, but it does say something about the glacial pace of EU reforms. Nevertheless, we are now seeing a very real light at the end of this regulatory tunnel. Last month, the Council of the European Union and representatives of the European Parliament came to an agreement on the draft regulations. They still need to be approved by the Council’s Permanent Representatives Committee and and the Parliament’s Committee on Environment, Public Health and Food Safety, but, barring any unforeseen road blocks, this is described by observers as little more than a formality.

“The agreed two draft regulations are expected to achieve a two-fold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner,” said the European Council in a press release issued on May 25. The official text was not made available, but the Council highlighted a number of key objectives designed to strengthen the rules for placing devices on the market and tightening post-market surveillance. The Pip implant scandal looms large in the emphasis on oversight.

To recap, the French maker of breast implants Poly Implant Prothèse (Pip) was discovered to be fraudulently using industrial-grade rather than medical-grade silicone in its products. Pip fooled its auditors, who would inform the company ahead of time that they would be conducting a facility visit, simply by hiding the noncompliant silicone while they were touring the plant. When the practice became known in 2010, worldwide outrage led to the drafting of a rule that requires the auditors, known as Notified Bodies, to conduct unannounced visits. That is one of the key provisions in the draft medical device regulation.

“The new rules will strengthen the surveillance of these so-called notified bodies by national authorities,” notes the Council in the press release. “They will also give these bodies the right and duty to carry out unannounced factory inspections. Notified bodies will have to ensure that they have available qualified personnel,” adds the release. There has been much discussion over the years about the level of competence among some notified bodies and the varying standards in place depending on the organization and, sometimes, even on the country where it is headquartered. (It was common practice for many years for medical device OEMs to shop around for a compliance assessment body known to be more forgiving in its audits.)

Post-market surveillance also is tightened in the draft regulations by requiring manufacturers to follow up on the “quality, performance and safety of devices placed on the market.” The measures include stated responsibilities in terms of liability and registering complaints, notes the press release.

Medical implantables and other high-risk devices may undergo an additional assessment by a panel of experts under the draft regulation. This provision has been widely debated as it could delay time to market and affect a key competitive advantage of the EU over the United States and the FDA approval process. Many medical device companies have employed a “Europe first” strategy over the years, as the approval times were significantly more advantageous than in the United States.

In an effort to improve transparency, the draft regulation also calls for the establishment of a central database compiling “economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates,” according to the release. Patients with an implanted device will be provided with “key information on the product, including any precautions that might need to be taken.”

For medical device OEMs and their supply chain doing business in Europe, the rule requiring unannounced audits has the potential to cause the greatest disruption. As PlasticsToday reported in “Be prepared: The auditors are coming,” published in September 2014, “if you are involved in the manufacture of a medical device that is placed on the EU market—and that applies to "critical" and "crucial" links in the supply chain, not just the company that puts its name on the product—you could be on the hook for a surprise visit from a notified body. Unannounced audits are to be conducted at least every three years, more frequently if high-risk devices are being placed on the market. These visits are in addition to the regular certification audits prescribed in the EU medical device directives.”

With all of that said, the draft regulation has been welcomed by industry associations and pundits. “Despite the sweeping overhaul, many of the proposed updates in the regulations are welcomed by our industry as they will enhance patient safety and facilitate access to new technology for patients,” writes Serge Bernasconi, CEO of the pan-European industry association MedTech Europe, in his blog. “I believe that the new regulations are critical in filling in the gaps of the existing laws and in bringing a more harmonized set of guidelines across the region.”

Assuming that the Council and Parliament committee endorse the agreement, which is expected this summer, and following translation of the text and its formal adoption, the new rules will enter into force three years after publication for medical devices and five years for IVDs.