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How Are EU Device Regulations Changing and When?

Screen Shot 2014 04 15 at 3.01.52 PM 238x300 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:

  1. Medical Device Directive (MDD), 93/42/EEC (http://bit.ly/M5MDD)
  2. Active Implantable Medical Devices (AIMD) Directive, 90/385/EEC (http://bit.ly/AIMDDirective)
  3. 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:

  1. The Commission will have the opportunity to review recommendations for CE Marking before approval (i.e., the Scrutiny Process)
  2. The ability to create Common Technical Specifications will be expanded from IVDs to all devices
  3. A new class of “Special” Notified Bodies will be created
  4. Notified Bodies will be audited jointly by Competent Authorities
  5. Unannounced audits will be enforced
  6. 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
  7. Most IVD products will require Notified Body involvement
  8. A Unique Device Identifier (UDI) system will be required for labeling, and the Eudamed database will be expanded
  9. 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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EU Medical Device Proposed Regulations: The “Scrunity Process”

This blog discusses the “scrutiny process” of the proposed EU medical device regulations, whereby authorities can take a 2nd look at audit findings…

For those of you that are not familiar with the “Scrutiny Process,” I am referring specifically to Article 44 of the proposed EU regulations for medical devices. This process is first alluded to at the end of section 3.5 in the “Explanatory Memorandum” (i.e., the 13 pages preceding the proposal for the regulation of medical devices).

The U.S. already has a pre-market approval process that we fondly refer to as the PMA process. In response to the PIP scandal, the European Parliament’s ENVI Committee (Committee on the Environment, Public Health, and Food Safety) proposed a pre-market approval process as part of a press release issued on April 25, 2012. In response to this political pressure, the Commission has proposed a “Scrutiny Process” that involves the preparation of a Notified Body “Summary Evaluation Report,” and verification that the conformity assessment was adequate by the Coordinating Competent Authority.

A similar process is outlined in MEDEV 2.11/1 rev. 2, a guidance document regarding animal tissues, and the Commission Regulation (EU) No 722/2012 of August 8, 2012. The proposed scrutiny process allows competent authorities to take a “second look” and review the findings of the Notified Body that would be issuing a CE Certificate for these high-risk devices. The review process is supposed to be concluded within 60 days, but the review time limit is suspended if the Competent Authorities request additional information or product samples within the first 30 days.

In section 3.5 of the Explanatory Memorandum, the Commission states that this scrutiny process “should be the exception rather than the rule and should follow clear and transparent criteria.” The criteria for invoking the scrutiny process are defined in five points 5a) through 5e) of Article 44. The five points leave room for interpretation by Competent Authorities, and the medical device industry is concerned that the review process for Class IIb and Class III devices will be delayed by at least 60 days regularly. The process could easily be delayed by as much as six months when there are requests for additional information and samples.

The “Legislative Financial Statement” (i.e., – the 19 pages immediately following the proposal for the regulation of medical devices) defines a monitoring process for the scrutiny process in the “Indicator of results and impact” (Section 1.4.4). The risk of delaying access to the market for innovative devices is also identified in the “Risk(s) identified” (Section 2.2.1). Therefore, the need for a control mechanism is recognized in “Control method(s) envisaged” (Section 2.2.2). This will be the responsibility of the Commission to draft a guidance document to define the control method(s). Until industry has an opportunity to review such a guidance document, executives will continue to voice their concerns and apply their own political pressure to the European Parliament.

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