In an article written by Jamie Hartford and published in MDDI, indicates that new EU medical regulations are expected to be finalized this year or next. In an earlier blog, we wrote on the pending regulations and the impact it might have on the medical device industry.
The Poly Implant Prothese breast implant scandal (PIP scandal) was a key catalyst behind the proposed changes. In September 2012, the European Commission released a proposal for new regulations. These regulations are intended to prevent similar events from occurring. The European medical device regulations (EMDR) are poised to be the most sweeping changes to medical device regulations since the 1990s, with industry experts concerned that the new regulations will increase costs and eliminate early access to device innovations that patients in Europe currently experience when compared to the balance of the world.
Hartford’s article outlines the most significant changes from the original proposal:
- 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.
- Notified Bodies will be audited for compliance with the new regulations jointly by Competent Authorities (i.e., the regulatory body for each member state). Until 2013, audits of Notified Bodies were performed only by the Competent Authority from the member state in which the Notified Body is located.
- Manufacturers will be subject to unannounced audits by Notified Bodies.
• Spinal implants, devices that control and monitor active implants, nano materials, aphaeresis 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.
Manufacturers are concerned about the potential impact of the regulations. One of their biggest concerns is Article 44, a scrutiny process allowing authorities to take a second look at the Notified Body’s review of technical documentation prior to CE marking approval. This could lead to a delay in the submission process eliminating a potential market advantage of being the first to market in Europe.
The final version of the EMDR is expected to be approved in late 2014 or early 2015. The original 2012 proposal outlined that there would be a three-year transition period (2014-2017) for implementation of the new regulations. The transition would begin with the highest-risk Class III devices. Lower-risk devices would be phased in over the three-year period.
Do you think the new regulations will be an improvement? Do you share concerns being outlined by medical device manufactures? Share you thoughts with us.
Photo Credit: tristam sparks