Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Eucomed: Ease Regulatory Requirements for Smaller-tier Medical Device Makers

European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation.

Eucomed has published a position paper, European Health and SMEs: Big Challenges, Small & Medium Sized Solutions, following a survey the group conducted over the course of 2010 of 12 European national medical technology industry associations to pinpoint major regulatory barriers to SMEs. Based on those survey findings, Eucomed has made four broad recommendations to EU regulators that the group argues will reduce unnecessary compliance requirements for smaller-tier medical device manufacturers.

First, Eucomed suggests a coordinated and transparent market surveillance program able to target specific product groups for both domestic and imported devices.

Second, the trade group argues for faster commercialization of “novel technologies” in order to expedite patient access to cutting-edge treatment and products.

Third, easier application processes for research and design funding programs should be established so that SMEs can more effectively access those funds.

Fourth, Eucomed urges broader information sharing among member state competent authorities pertaining to market access models and distribution channels to increase the overall size of the European medical device market.

On a related note, the trade association has suggested more transparent and predictable purchasing processes across the EU to clear up persistent questions about reimbursement and procurement; Eucomed also recommends scaled down Health Technology Assessment procedures be made available to SMEs with limited resources. (Eucomed plans to issue a separate document more fully discussing these two suggestions at a later, unspecified date.)

Furthermore, Eucomed has requested that the European Commission conduct a comprehensive survey of SMEs in the medical technology industry in order to more fully identify these firms’ operational needs and characteristics.

Markets: EuropeCategories: Regulatory ComplianceTags: EU, Eucomed, european commission, European Medical Device Directive, Health Technology Assessment, HTA, medical device, SME

Author: Stewart EisenhartDate: March 23, 2011

EU: Broad Support for IVDD Revisions

Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate strong support for adopting a risk-based classification for in vitro diagnostic devices (IVDs).

Among 116 manufacturers, notified bodies and other medical device industry stakeholders that provided comment, 93% of respondents saw the adoption of risk-based IVD classification based on the Global Harmonization Task Force (GHTF) model as a positive development, allowing for greater flexibility, stronger public health protections and timely market access for new products.

The cost of such a reclassification, however, was also highlighted by some respondents. Specifically, classification according to GHTF standards would necessitate greater regulatory involvement to handle conformity assessment procedures. In turn, manufacturing costs would increase, ultimately driving up prices for end users as well.

Nonetheless, respondents noted that additional costs would likely be offset by improved public health protections, and suggested a five-year transitional period for manufacturers to adjust to the new risk-based classification and its ensuing requirements. In addition, a risk-based IVD classification incorporating the GHTF model would boost European exports, some participants stated, but only if such classification were based on that model—otherwise, additional regulatory costs would not be offset by any financial benefits.

At this point, the EU Commission may discuss and consider these comments and then provide a draft which will likely include GHTF classification rules.

If EU regulators end up adopting these classification rules, Europe will become the second major market after Australia to implement GTHF risk-based classification rules for IVDs.