Medical device regulations, classification and submissions

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Medical devices play a crucial role in the diagnosis, prevention, monitoring and treatment of diseases. Unlike drugs or biologics, a medical device can vary from the simple, which poses little or no risk to the user (for example, a toothbrush), to the life-sustaining (for example, a pacemaker). The technology and design can rely on any combination of mechanical, electronic, software or chemical/biochemical action to achieve their purpose.^1,2 Registration processes (that is, to reach regulatory clearance or approval) for medical devices vary greatly across jurisdictions.

Classification and data requirements

Due to the wide variety of medical devices, these products are regulated on a risk-based classification system. In Canada and the EU, devices are grouped into four different classes. In the US, they are divided into three groups. Generally, the higher the risk of the medical device, the higher the medical device classification. And with a higher classification come more stringent data requirements to demonstrate the device’s safety, effectiveness and performance (Figure 1).

Figure 1: Relationship between medical device classification and data requirements

Procedures to classify medical devices

The classification procedures in Canada and the EU are quite similar―manufacturers must classify their medical devices according to the rules and criteria set out in the relevant medical device regulations (Canada) and directives (EU), as indicated in Table 1.^2-5

In the US, the classifications and ancillary information relating to medical device regulations are published in US Code of Federal Regulations (CFR), Title 21, Parts 862–892. These were introduced in 1976 when the U.S. Food & Drug Administration (FDA) mandated expert advisory panels (classification panels) to consider the different types of medical devices on the market based on the intended user, intended use, the risk-to-benefit ratio and the reliability of the device.

In the US, manufacturers of a new medical device can determine its classification by comparing its intended use and technological features to those that have already been classified. However, if the device is technologically innovative with no existing predicate device, it will automatically be classified as class III. Manufacturers of class III medical devices may petition the FDA for a lower classification via a “de novo” process, based on supporting objective scientific evidence as to the device’s safety and effectiveness. ^2-5

Regulations or directives related to medical device classification

Jurisdiction	Applicable medical device regulations/ directives3,4,6,7
Canadai	Medical Devices Regulations (SOR/98–282). Schedule 1. Classification rules for medical devices. Part 1 – Medical devices other than in vitro diagnostic devices Part 2 – In vitro diagnostic devices
US	Code of Federal Regulations (CFR), Title 21, Parts 862–892
EUi	Medical Device Directive 93/42/EEC regulates most devices. Classification rules are listed in Annex IX of the directive.1 Active Implantable Medical Devices (AIMDs) Directive 90/385/EEC. AIMDs are regulated as high-risk devices. In Vitro Diagnostics (IVDs) Directive 98/79/EC. Most IVDs are regulated as low-risk devices, except for tests that underpin the safety of blood and blood products (blood group, HIV and hepatitis tests), where additional specific requirements equating to a high-risk category apply. Subsequent directives:ii A number of additional directives amending the original directives have been introduced: Directive 2007/47/EC amends Directive 90/385/EEC and Directive 93/42/EEC Directive 2001/104/EC brings medical devices incorporating stable blood derivatives within the scope of the general directive Directive 2003/12/EC reclassifies breast implants into class III Directive 2003/32/EC relates to medical devices that are manufactured utilizing tissues of animal origin Directive 2005/50/EC reclassifies total hip, knee and shoulder joints into class III

Going to market: Medical device licences and registration

Canada

Manufacturers, distributors and importers who wish to sell a medical device must obtain an establishment licence for class I devices. For class II, III or IV medical devices, the company must obtain a medical device licence issued by Health Canada. To do so, they must submit a device licence application and include a certificate demonstrating compliance to ISO 13485:2003. The application for class II devices is administrative in nature. Applications for class III devices are based on the submission of summary documents, and those for class IV devices are based on extensive data, including all study reports, quality plan, risk assessments and so on. ^5,8,9

US

Most class I (and also a few class II) medical devices are exempt from registration requirements as specified in the CFR Parts 862–892. If registration is exempted, the manufacturer must register their establishment with the FDA and comply with the applicable Quality System Regulation (QSR), labelling and medical device reporting requirements. For other class I and II devices that are subject to Premarket Notification, a 510(k) application must be submitted for FDA clearance. If the device is classified as a class III device, the manufacturer must go through the Premarket Approval (PMA) procedure, or the de novo procedure to reclassify the product in a lower-risk category before placing it on the market. ^5,8,9

EU

For low-risk medical devices (most class I and certain class IIa devices), the manufacturer may make a declaration of conformity with the essential requirements, based on a self-assessment without the involvement of a Notified Body.ⁱⁱⁱ For other medical devices, a Notified Body’s involvement is required. ^5,8,9

Technical documentation in the EU
Technical documentation that provides evidence of conformity with the Essential Requirements as specified in the directives is fundamental to the conformity assessment procedures. The Essential Requirements are listed in Annex I of the Medical Device Directive 93/42/EEC and its corresponding amendments (Table 1). The technical documentation should include relevant performance data, procedures, standards, labelling, certifications by a Notified Body and/or the manufacturer’s declaration of conformity. The technical documentation must be maintained at the disposal of the Competent Authorities (national authorities in the EU Member States) for a period of five years after manufacture of the last product. Requests from Competent Authorities to view the technical documentation will usually be triggered by problems in the market.

ⁱ If more than one rule applies, a medical device must be assigned the highest class that applies under the various rules.
ⁱⁱ On September 26, 2012, the European Commission proposed regulations that would overhaul the medical device regulatory framework in the EU—one proposal for general medical devices, including active implantables,¹¹ and another for in vitro devices¹²—imposing tougher rules for assessing the safety and monitoring the use of medical devices and implants. The proposed legislation must be jointly approved by EU governments and lawmakers, which could take up to two years.¹³ If you are developing a medical device for the EU market, make sure to follow the development of these regulations.
ⁱⁱⁱA Notified Body is certification organization that the national authority (the Competent Authority) of an EU Member State designates to carry out one or more of the conformity assessment procedures described in the annex(es) of the EU Directives. It must be qualified to perform all the functions set out in any annex for which it is designated.¹⁰

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Summary: For medical devices, regulatory clearance/approval/licensing procedures vary across jurisdictions, with more stringent requirements applied depending on the level of risk associated with the product.

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Disclaimer

The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.

Published: October 17, 2012

References

1. European Commission. (2012). Public Health. Medical devices. Retrieved July 16, 2012, from http://ec.europa.eu/health/medical-devices/index_en.htm.
2. Tobin, J.J. & Walsh, G. (2008). Chapter 9. Medical devices. In Medical product regulatory affairs. Pharmaceuticals, diagnostics, medical devices. Weinheim: Wiley-VCH Verlag GmbH & Co.
3. Canada. Medical devices regulations. (2012, June 27). Retrieved July 16, 2012, from http://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-23.html#h-68.
4. United States Code. Title 21, Parts 862–892. Retrieved October 9, 2012, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.
5. U.S. Food and Drug Administration. (2012, September 24). Evaluation of Automatic Class III Designation (De Novo) Summaries. Retrieved September 26, 2012, from http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm232269.htm.
6. EurLex. (1993, June 14). Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Retrieved July 16, 2012, from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML.
7. European Commission. (2009, June 5). Implementation of Directive 2007/47/EC amending Directives 90/385/EEC, 93/42/EEC and 98/8/EC. Retrieved July 16, 2012, from http://www.mhra.gov.uk/home/groups/es-era/documents/regulatorynews/con049176.pdf.
8. Tobin, J.J. & Walsh, G. (2008). Chapter 10. Authorisation of medical devices. In Medical product regulatory affairs. Pharmaceuticals, diagnostics, medical devices. Weinheim: Wiley-VCH Verlag GmbH & Co. KGaA.
9. Petty, N.L. (2004). Chapter 6. Medical device submissions. In 2004 Fundamentals of Canadian Regulatory Affairs. Washington: Regulatory Affairs Professionals Society.
10. The Medicines and Healthcare products Regulatory Agency. (2006, January). The Notified Body: Bulletin No. 6. Retrieved September 25, 2012, from .
11. European Commission. (2012, September 26). Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. Retrieved October 14, 2012, from http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf.
12. European Commission. (2012, September 26). Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices. Retrieved October 14, 2012, from http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_541_en.pdf.
13. Zornoza, L. (2012, September 27). European Commission Proposes Major Overhaul of EU Device Legislation. Regulatory Focus.