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Impact Of New European Regulations
On Outsourcing Of Medical Devices

During the last two decades, there has been a steady increase in the outsourcing of medical device manufacturing to contract manufacturers, service providers, and component suppliers in European Countries. The medical device approval process in European Countries has generally been guided by national law where a conformity assessment is performed by a notified body and the device obtains a CE marking meaning it can be sold in the European Economic Area.

However, over the past few years there has also been an increase in the frequency of recalls and increased scrutiny of the supply chain by regulators. The new European Medical Device Regulation (EMDR) places additional burden on manufacturers and their suppliers.

Medical device companies will operate under a stricter regulatory environment in Europe following the approval of new regulations governing medical devices and in vitro diagnostics by the Council of the European Union. The Council proposes stricter requirements on medical device manufacturers, who would be required to:

  • Create a post-market surveillance system appropriate to a device’s type and risk class

  • Submit periodic safety update reports (PSURs) akin to pharmaceutical requirements

  • Appoint a person with “requisite expertise” in the field of medical devices to be responsible for regulatory compliance

  • Respond more quickly to public health threats or deaths linked to medical devices

  • Conduct clinical investigations demonstrating the safety and performance of highest-risk (Class III) devices

  • Consult with an expert panel to review the manufacturer’s clinical development strategy

  • Submit post-market clinical follow-up plans and post-market studies of an equivalent device, provided the device is designated as equivalent by the notified body, or designated as a modification of a device already marketed by the same manufacturer

  • Notified bodies will undergo a stricter designation process and increased monitoring by competent authorities, but they also will be given authority to carry out unannounced factory inspections

This means trial costs are going to increase as there would be a need to collect additional clinical data to demonstrate efficacy and safety of a medical device. The EMDR is also pushing for greater data transparency meaning companies will need to prepare data in a traceable and readily available way to respond to any liability issues.

Increased Frequency of Audits

Manufacturers are required to demonstrate control of suppliers and records of evaluating suppliers. The most common practice is to categorize suppliers as having either “critical” or “non-critical” status.

Increased frequency of audits and audits of more suppliers will stretch the human resources of suppliers and manufacturers alike. Ultimately, manufacturers will need to consider alternative solutions to on-site audits, such as remote auditing and sharing audit reports with other manufacturers.

Labeling and Packaging

If packaging and labeling is outsourced, then suppliers must invest in new equipment and software to implement on demand printing.

Implementation of Revised ISO Standards

In parallel with changes to the medical device regulations for Europe, the quality system standards (i.e., ISO 9001 and ISO 13485) will also be changing. ISO 9001:2015 is expected to be released in October 2015, and the DIS2 for ISO 13485:201x was just released for comment. If these revised standards are harmonized, then contract manufacturers will be forced to implement these changes in order to meet the CE Marking requirements.

If contract manufacturers want to survive during this period of tougher European regulation, contract manufacturers and component suppliers need to be proactive and get additional training. Training needs to include general quality system requirements, EMDR. Suppliers should also consider developing new quality agreements to address the new regulations.