How Are EU Device Regulations Changing and When?
This blog, “How Are EU Device Regulations Changing and When?” includes 9 of the most significant proposed changes and compliance deadlines.
The CE Marking process for medical devices is currently defined in three directives:
- Medical Device Directive (MDD), 93/42/EEC (http://bit.ly/M5MDD)
- Active Implantable Medical Devices (AIMD) Directive, 90/385/EEC (http://bit.ly/AIMDDirective)
- In Vitro Diagnostics Directive (IVDD), 98/79/EC (http://bit.ly/currentIVDD)
The EU Commission proposed revising the system from three directives requiring transposition by member states to two regulations: 1) http://bit.ly/EUIVDProposal, and 2) http://bit.ly/EURegs. The most significant proposed changes are:
- The Commission will have the opportunity to review recommendations for CE Marking before approval (i.e., the Scrutiny Process)
- The ability to create Common Technical Specifications will be expanded from IVDs to all devices
- A new class of “Special” Notified Bodies will be created
- Notified Bodies will be audited jointly by Competent Authorities
- Unannounced audits will be enforced
- Spinal implants, devices that control and monitor active implants, nanomaterials, apheresis machines, and combination products will be reclassified as Class III devices requiring a Design Dossier
- Most IVD products will require Notified Body involvement
- A Unique Device Identifier (UDI) system will be required for labeling, and the Eudamed database will be expanded
- Formatting of Declarations and Technical Files will be revised
When Will, the Final EMDR, be Approved?
The EU Commission took from February 2012 to September 2012 to write a proposal for new European device regulations. Parliament took 13 months (i.e., September 2012 to October 2013) to revise and fast-track its version of the new European device regulations, and the Council will probably take a year to finish their version of the regulations. Therefore, the real negotiations between Parliament and the Council will begin after the 2014 summer holiday. The final approval date is unknown, but my current guess is October 2015.
On September 12, 2013, Eucamed released the results of an industry survey (http://bit.ly/CostofEURegs) stating that the proposed regulations are expected to increase the cost of regulatory approvals by 17.5 billion Euros for medical device manufacturers collectively. The details of the survey indicate that implementation of the UDI system improved labeling and clinical performance data will require a 7.5 billion Euro investment to implement new software systems to comply with the UDI regulations. Also, industry survey respondents indicated that an additional 2.5 million Euro investment would be required for each new Class III device that is required to undergo the proposed Scrutiny Process in Article 44. Financial implications and political pressures could force the Council and Parliament to make major revisions to the proposed regulations to reduce the cost of implementation.
Some key elements need to be in place before implementation of the proposed regulations can reasonably begin. First, Notified Bodies need more staff to conduct audits and review technical documentation–especially for high-risk devices. Second, the European Databank of Medical Devices (i.e., Eudamed) must be ready to implement UDI labeling and other documentation required by the EMDR (http://bit.ly/Eudamed). Third, the European Commission plans to build a new centralized organization that will be responsible for oversight of the Notified Bodies. Each of these three elements will take more than a year, and planning has only just begun.
What Is The Compliance Deadline?
The original proposal, released in September 2012, indicated that there would be a three-year transition period for implementation of the EMDR from 2014 to 2017. This transition period would begin with the highest risk Class III devices first, and lower risk devices would be phased in over the three years. However, if the EMDR was finalized in October 2015, the implementation period will end at the end of 2018.
A complete review of the new regulations can be found at http://bit.ly/MDDI-article-EU-Device-Reg-Changes.
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