NEW EU MEDICAL DEVICE REGULATIONS

Every time there is a major public health scandal, governments respond with “new and improved” regulations. Such has been the case in the wake of the Poly Implant Prothèse breast implant scandal, in which the French manufacturer substituted approved medical-grade silicone with industrial-grade silicone that resulted in rupture of the implants and systemic health problems, including death.

In September 2012, the European Commission released a proposal for new European medical device regulations (EMDR) intended to prevent similar events from occurring in the future. The final regulations were expected to be published this by March- April 2016.

The below are the Expected Changes

Since their release, the proposed regulations have become a bureaucratic Frankenstein, with many deviations from the original proposal. The following are the most significant changes:

• The European Commission will be able to review recommendations for CE Marking prior to approval (i.e., the scrutiny process).
• The European Commission’s ability to create common technical specifications (CTS) will be expanded to all devices.
• Only newly created Special Notified Bodies will be able to issue CE Certificates for high-risk devices such as implants.
• Manufacturers will be subject to unannounced audits by Notified Bodies.
• Spinal implants, devices that control and monitor active implants, nanomaterials, aphoresis machines, and combination products will be reclassified as Class III devices requiring technical documentation known as a design dossier.
• Most in vitro diagnostics (IVDs) will require Notified Body involvement.
• A Unique Device Identification (UDI) system will be required for labeling, and the European Databank on Medical Devices (Eudamed) will be expanded.
• Formatting of declarations of conformity and technical files will be revised.

Expected Impact on Manufacturers across the Globe waiting for CE Certification

A scrutiny process allowing authorities to take a second look at the Notified Body’s review of technical documentation prior to CE marking approval. The scrutiny process will require Notified Bodies to prepare a summary report of the technical review for an oversight group prior to approving CE Marking of high-risk devices. The oversight group may request additional information and testing results, potentially delaying the submission process by several months and thus reducing the market advantage of launching products in Europe first.

These joint audits have already resulted in the closure of two noncompliant Notified Bodies. Further attrition may occur if Notified Bodies are unable to qualify as Special Notified Bodies for high-risk devices. This will reduce revenues for Notified Bodies and force smaller Notified Bodies to merge or go out of business. Consolidation of Notified Bodies will also force many manufacturers to transfer from their current Notified Body to one of the few Special Notified Bodies that can issue CE Certificates for high-risk devices. This will increase the overall expenses for the manufacturer waiting for CE Certification.

IVD manufacturers will experience the most significant changes under the new EMDR. Currently, only one in five IVD products require Notified Body involvement, but expected changes will require 80% – 90% of these products to have Notified Body involvement. Be aware!!!

Existing CE Certificate holders as per MDD regulated devices will need to be reclassified to Class III and require a design examination certificate. These product specific CE Certificates require review and approval of all design changes, whereas under the current system, only significant changes require review and approval.

Manufacturers will also be required to update the format of technical files, declarations of conformity, and labeling. The new format requires manufacturers to create a summary document for each section instead of providing complete protocols and reports.

Currently, there is only vague guidance for the format and content of a declaration of conformity, but the proposed regulations include a prescriptive outline for format and content. The new format must also include a UDI, requiring labeling for all device classifications to be changed. In addition, manufacturers will be required to more clearly disclose any residual risks associated with a device.

The original September 2012 proposal indicated that there would be a three-year transition period (from 2014 to 2017) for implementation of the new regulations. The transition would begin with the highest-risk Class III devices, and lower risk devices would be phased in over the three years. However, if the EMDR are finalized in April 2016, the implementation period will end in late 2019.

Thanks for reading this article.
Mrs. Sakthisri [Senior Consultant]

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