[4]  Medical devices must be in conformity with the rules established by these directives prior to being marketed and/or put into service in the EU, the European Economic Area, or Switzerland.  At the EU level, there is no centralized approach similar to that in the United States. Clinical trials in Europe must be pre-approved by a European Competent Authority. [19], A number of Member States urged the Parliament to establish a centralized EU premarketing approval process along the lines of the US system.  It appears that the Parliament has not introduced such a procedure. Stringent, … Active implantable medical devices are typically subject to the same regulatory requirements as Class III devices. The Medical Device Regulation (MDR) will replace … Step 4 The CE mark is a legal requirement to place a device on the market in the EU. The procedures required to legally place a medical device on the market vary in Canada, the US and the EU. 16; Directive 90/385/EEC, supra note 2, art. ´Classification of medical device… For a more detailed look at the European regulatory process for medical devices, download the chart below. All medical devices placed onto the European market need to be subject to an appropriate post market surveillance process. [9], Medical devices are grouped into four product classes: I, IIa, IIb, and III.  Application of the classification rules is based on the intended purpose of the devices.  Most devices fall within the classification rules, except for a small number of products that are difficult to classify, such as borderline products or those with an unusual nature.  Classification rules are in conformity, to a large extent, with the classification rules established by the Global Harmonization Task Force (GHTF).[10]. 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: [20]  The proposal is expected to be adopted in 2014 and would gradually be implemented between 2015–2019. Currently, medical device manufacturers often launch products in the European Union before the United States, because the EU approval process is considered simpler than the FDA’s. Press | This includes certification, Notified Body and consultancy services. Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Directive. Accessibility | CE Marking certificates are typically valid for 3 years. Step 6 We have deep expertise with a range of product types, including combination and borderline products. For Classes I through IIb, prepare a Technical File that provides detailed information on your medical device, and demonstrates compliance with 93/42/EEC. For all devices except Class I (non-sterile, non-measuring), your QMS and Technical File or Design Dossier must be audited by a Notified Body, a third party accredited by European authorities to audit medical device companies and products. For a more detailed look at the European regulatory process for medical devices, download the chart below. Gain market access in Europe with CE mark. Step 7 In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. [3] Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, 1993 O.J. 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