EU Mandates Fast-Tracking Changes to the CE Mark Approval Process

EU Parliament is fast-tracking changes to “New Approach” and the CE Mark approval process. Impact of October 22 plenary vote is reviewed and predictions made.

The “New Approach” was applied to CE Marking of medical devices in the 1990s when member states adopted three “new approach” directives specific to medical devices:

1. Medical Device Directive, 93/42/EEC (http://bit.ly/M5MDD),
2. Active Implantable Medical Devices Directive, 90/385/EEC (http://bit.ly/AIMDDirective), and
3. In Vitro Diagnostics Directive, 98/79/EC (http://bit.ly/currentIVDD).

The “Old Approach” Directives were extremely detailed. EU member states introduced national standards and regulations faster than the Commission could finalize the “Old Approach” Directives. These national standards and regulations created trade barriers within the EU. Therefore, on May 7, 1985, the European Council resolution was proposed as “a new approach to technical harmonization and standards” (http://bit.ly/CouncilResolution1985).

Basics of the “New Approach”

The “New Approach” Directives (http://bit.ly/EuropaNewApproach) rely heavily upon International Standards, and the Directives are limited to Essential Requirements for Health & Safety. Implementation of the “new approach” directives allows for medical devices to be CE Marked by the manufacturer if the manufacturer completes one of the conformity assessment procedures identified in the applicable Directive.

Typically, Class I devices are self-certified by the manufacturer, while Class IIa, IIb and Class III devices require Notified Body (NB) involvement. Each NB interprets the Directives slightly differently, and the competent authority presiding over each NB audits the NB for compliance with the Directives. These differences are not ideal, but the process enables rapid approval of CE Marking applications because there is no centralized review process—unlike the US FDA.

The Council Resolution of 1985 states that the EU Commission shall review new International standards to determine if the standards are harmonized with the requirements of the applicable Directive (s). If not, the Commission may identify the shortcomings of those standards. A list of the harmonized standards is maintained on the Europa website. The following is a link to the standards harmonized with the MDD: http://bit.ly/ENHarmonizedStandards. For more information about the implementation of the “New Approach,” you can download a guidance document from the Europa website: http://bit.ly/Resolution85.

Politics of the Plenary Vote

Erik Vollebregt (http://bit.ly/ErikVollebregt) wrote an excellent analysis on October 21 (http://bit.ly/10minutestomidnight) about the flaws in the rapporteur’s (http://bit.ly/DagmarRoth-Behrendt) arguments for the draft legislation. In one of his earlier blog postings, however, he predicted that the EP would vote in favor of the draft legislation. Amanda Maxwell (http://bit.ly/AmandaMaxwell) wrote another article in Clinica on October 18 (http://bit.ly/TwoPossibleOutcomes). She predicted two possible outcomes.

The first possible outcome was a mandate from the EP for the rapporteurs to negotiate a final text for the Medical Device Regulations (MDR, http://bit.ly/DraftMedicalDeviceLegislation) with the European Council (i.e., fast-track procedure).

The second possible outcome was a vote of the text as the first reading position of the EP. Due to the European legislative process (http://bit.ly/EULegislativeProcedure), this outcome would result in a delay of final approval of the MDR beyond the April 2014 elections in Europe. On October 12 (http://bit.ly/EMDR-Frankenstein), I stated that I hoped for outright rejection of the draft legislation. Still, I predicted that we would have the worst possible outcome—an EP mandate to negotiate a final text with the Council.

Flawed Interpretations by the EU Commission

Instead of relying heavily upon International Standards, the EU Commission is identifying minor differences between the Directives and the International Standards. In the past, these differences would be resolved when competent authorities issued a guidance document (i.e., MEDDEVs). However, now the Commission is proposing to adopt new Common Technical Specifications (CTS) instead. This provision for adopting a CTS is found in Article 7 of the proposed regulations. The compromise amendments retained the provision in Article 7 for adopting a CTS, but Amendment 7 now indicates that a CTS shall only be adopted when harmonized standards do not exist, are not likely to be adopted within a reasonable period, “have become obsolete or have been demonstrated as clearly insufficient according to vigilance or surveillance data.”

The seven deviations identified in the EN ISO 14971:2012 Standard (http://bit.ly/riskblogs) are an example of how the EU Commission is using literal interpretations of the Directives to subjugate the CE Marking process to a corrupted version of the ground-breaking “New Approach.” The details of the EP changes are not yet available, but I suspect Amendment 7 will not change. What is also unclear is if the Commission will continue to insist that International Standards do not meet the letter of the law and therefore are inadequate. It is quite scary to think that politicians and lawyers believe they know better than a committee of international subject matter experts.

An EP Improvement? – New Approach v2.0

The Plenary vote today introduced some new regulations that did not exist in the draft legislation, and the EP mandated negotiation with the Council. Early reactions to the vote were published by Eucomed (http://bit.ly/EPImprovement) and Clinica (http://bit.ly/Clinica-EUFast-Track). These reactions were more positive than I expected, but I fully expect Eucomed to return to its position of criticizing the EP version of regulations before the holidays arrive.

The European Parliament (EP) is rewriting the strategic plan for medical device regulation in Europe. Eliminating the European Medicines Agency from the mix (Article 44a) and replacing it with an “improved” scrutiny process (Article 44, rev 2?) will not substantially accelerate approval of CE Marking applications for high-risk devices. Companies are already frustrated by delays at Notified Bodies and multiple rounds of questions during the review process. The addition of scrutiny by the proposed Medical Device Coordination Group (MDCG), established in Article 78 of the proposal, will increase the costs and delays associated with the CE Marking process. Instead of a streamlined process that allows innovative medical devices to get to market quickly, the EP has created a Frankenstein of regulatory bodies that will result in skyrocketing healthcare costs and bring the flow of innovative devices to a screeching halt.

The EP has mandated that the rapporteurs negotiate a final text with the Council. The EP knows that the member states cannot afford this “stricter” process, and medical device companies cannot afford it either. I predict this will be an ugly political war between the Council and the EP. I also have zero confidence that the EP approach to the MDR will prevent scandals and unsafe products from getting to market. Scandals (http://bit.ly/MHRAReport) and safety issues associated with Metal-on-Metal (MoM) hip implants (http://bit.ly/MoMImplantLessons) are post-market problems—not weaknesses in the CE Marking approval process. I hope that the Council’s counter-proposal to the rapporteurs will be different, but what if it’s worse?

Is anyone interested in learning about Canadian Medical Device Licensing (http://bit.ly/ClassificationforHC)?