I. European Union
A. Current Medical Device Approval Process
The current European Union (EU) regulatory framework governing medical devices includes Council Directive 90/385/EEC on Active Implantable Medical Devices and Council Directive 93/42/EEC on Medical Devices. In vitro diagnostic medical devices are governed by Directive 98/79/EC. 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. The European Medicines Agency of the EU, unlike the Federal Drug Administration in the United States, is not involved in the approval process of medical devices. Manufacturers, prior to placing their devices in the market, are required to determine the classification of a device, based on the risk factors associated with each device, and then to apply the appropriate conformity route. Medical devices are assessed for efficacy and safety by notified bodies, which are private organizations staffed by experts and certified by the EU Member States. In the final stage, medical devices, with some exceptions for such things as custom made devices and devices intended for clinical investigation, are given a CE marking, which ensures that medical devices are in conformity with EU rules and are ready to be marketed.
EU Members are in charge of implementing the legislation and taking any measures required to ensure that medical devices meet the required criteria prior to being marketed in the EU and/or put into service. Medical devices and in vitro medical devices produced in third countries (outside the EU) must conform with the EU legislation.
1. Classification Rules
The first step in the approval process is taken by the manufacturer, who is required to determine the class of its medical device in order to apply the appropriate conformity assessment rule. Medical devices are classified on a “risk-based” system. The classification rules of medical devices, as established in Annex IX of Directive 93/42/EEC on Medical Devices, depend on the vulnerability of the human body, taking into account possible dangers inherent in the technical design and manufacture of the devices.
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).
2. Approval Process
In general, all devices must meet the essential requirements irrespective of the class of the devise, be subject to the reporting requirements under the national supervisory system, and be CE marked, except custom-made devices and those intended for clinical investigation. Clinical data are also required to ensure conformity with the requirements of the Medical Devices Directive for class III devices and implantable medical devices. The affixing of a CE marking on medical devices, which is the last stage in the approval process, indicates that those medical devices conform with the requirements provided for in the legislation. The legal value of the CE marking lies in its proof that the medical device concerned is in full compliance with applicable legislation. On the other hand, the CE marking does not represent quality, even though consumers often assume that products bearing the CE marking are of better quality than others.
For economic and practical reasons, medical devices are subject to a graduated system of control, whereby the level of control corresponds to the level of danger inherent in the type of device involved. For class I devices, the conformity assessment procedure can be carried out by the manufacturer alone, due to the low level of risk associated with such products. For class IIa devices, the intervention of a notified body is mandatory at the production stage. For devices falling under classes IIb, such as implants and contraception products, and III, which pose a high risk, the notified body is tasked with being involved in the design and manufacture of the devices.
Notified bodies play a vital role in the approval process since they are tasked to ascertain that medical devices marketed in the EU meet all requirements pursuant to the class assigned. Notified bodies are conformity assessment bodies, staffed by experts and designated as such by Member States. The Member States must report the names of the notified bodies to the Commission, which publishes a list of the bodies, along with the tasks assigned to them. Their accreditation and monitoring is conducted by the EU Members.
B. Pending Legislation
In 2012, the European Commission, due to diverging interpretations and applications of the legal regime on medical devices by the Members, new technological developments, and the public concerns raised by the scandal of a French manufacturer using industrial silicone for breast implants in France, moved to reform the legislation on medical devices. In brief, the pending legislation establishes new rules on the traceability of medical devices back to the suppliers; stronger supervision of independent conformity assessment bodies (notified bodies) by national authorities; and additional powers for notified bodies vis-à-vis the manufacturers, including unannounced inspections in factories.
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. The proposal is expected to be adopted in 2014 and would gradually be implemented between 2015–2019.
Global Legal Research Directorate Staff
 See Law Library Report for Congress: European Union Regulation of Medical Devices (LL File No. 2011-005058) (Dec. 2010) (on file with author).
 Council Directive 90/385/EEC of 20 June 1990 on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, 1990 O.J. (L 189) 17, as amended, http://eur-lex.europa.eu/legal-content/ EN/TXT/PDF/?uri=CELEX:01990L0385-20071011&rid=1.
 Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, 1993 O.J. (L 169) 1, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01993L0042-20071011&rid=1, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, art. 3, 2007 O.J. (L 247) 21, http://ec.europa.eu/health/medical-devices/files/revision_docs/2007-47-en_en.pdf.
 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices, 1998 O.J. (L 331) 1, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01998 L0079-20120111&rid=1.
 Boston Consulting Group, Regulation and Access to Innovative Medical Technologies: A Comparison of the FDA and EU Approval Processes and Their Impact on Patients and Industry (2012), http://www.eucomed.org/uploads/ModuleXtender/Newsroom/97/2012_bcg_report_regulation_and_access_to_innovative_medical_technologies.pdf.
 Directive 93/42/EEC, supra note 3, art. 4.
 Id. art. 2.
 Id. art. 9.
 Id., Annex IX.
 Id. art. 9 & Preamble.
 European Commission, DG Enterprise, Guidelines for the Classification of Medical Devices 4, meddev 2.4/1 Rev. 8, July 2001, http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf.
 Directive 93/42/EEC, supra note 3, Annex I.
 Id., Annex X.
 European Commission, supra note 11, at 2.
 Directive 93/42/EEC, supra note 3, Preamble.
 Id. art. 16; Directive 90/385/EEC, supra note 2, art. 11.
 Commission Implementing Regulation (EU) No. 920/2013 of 24 September 2013 on the Designation and the Supervision of Notified Bodies Under Council Directive 90/385/EEC on Active Implantable Medical Devices and Council Directive 93/42/EEC on Medical Devices, 2013 O.J. (L 253) 8, http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2013:253:0008:0019:EN:PDF.
 Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, COM (2012) 542 final, http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf; Proposal for a Regulation for In Vitro Diagnostic Medical Devices, COM (2012) 541 final, http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_541_en.pdf.
 Press Release, European Commission, Safer, More Effective and Innovative Medical Devices (Sept. 26, 2012), http://ec.europa.eu/health/medical-devices/files/revision_docs/pr_20120926_en.pdf.
 EU Parliament Stops Short of U.S.-Style Approvals for Medical Devices, Reuters (Oct. 22, 2013), http://www.reuters.com/article/2013/10/22/us-eu-medtech-idUSBRE99L0TH20131022.
 European Commission, Memo, Questions and Answers: Commission Tables Proposals for a New EU Regulatory Framework for Medical Devices and In Vitro Diagnostic Medical Devices (Sept. 26, 2012), http://ec.europa.eu/ health/medical-devices/files/revision_docs/qa_20120926_en.pdf.
Last Updated: 07/24/2020