THE EU IS MOVING FROM MEDICAL DEVICE DIRECTIVES TO REGULATIONS
Due to its private system of approvals, public healthcare system and expansive combined population, the European Union is often known for being the first market device manufacturers launch in. The regulatory system is The Notified Body (NB) system is a requirement of the EU medical directives designed to ensure that medical devices of moderate to high risk are assessed by an independent third party, such as UL for compliance and the continuance of that compliance with the Active Implantable Medical Devices Directive (AIMDD), Medical Devices Directive (MDD) or the In Vitro Diagnostic Device Directive (IVDD).
Prompted by rapid advances in medical device technologies and in part by recent findings of safety issues with previously approved devices, the regulation of medical devices in the European Union (EU) is undergoing a sweeping transformation. Current changes include an expanded scope of regulated devices, greater oversight and control of notified bodies, unannounced audits of suppliers and more. For most medical device manufacturers, these changes will directly impact the product review and certification process, and are likely to increase the investment of time and resources required for product approval.
The proposed regulatory changes are likely to have the greatest impact on manufacturers of in vitro diagnostic medical devices. In vitro diagnostics, which include chemicals and reagents, consumables and analyzers used in the evaluation of human specimens such as blood and urine, represent an annual global market value of approximately $50 billion (USD),[i] and are projected to exceed $22 billion (USD) in Western Europe alone by 2018.[ii] Under the proposed changes, nearly 80% of in vitro diagnostic medical devices sold in the EU could be subject to notified body approval, up from just 20% currently.
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[i] “Strategic Analysis of the Global In Vitro Diagnostic Market,” Frost & Sullivan, July 2010. Web. 1 April 2014. http://www.frost.com/
[ii] “An Ageing Population Boosts Demand for IVD Testing,” summary of report “Western European In Vitro Diagnostics (IVD) Market,” Frost & Sullivan, 25 June 2012. Web. 1 April 2014. http://www.frost.com/
July 1, 2016: Guidelines On The Qualification and Classification of Stand Alone Software Used in Healthcare Within the Regulatory Framework of Medical Devices
April 5, 2017: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
April 5, 2017: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on In Vitro Diagnostic Medical Devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
December 13, 2016: Decree No. 2016-1716: Medical Device Characteristics Summary
August 25, 2016: Guidance: Medical Device Stand Alone Software including Apps (including IVDMDs)
October 4, 2016: Guidance on Class I Medical Devices
March 29, 2017: Guidance on Medical Devices: Virtual Manufacturing replaces Own Brand Labelling