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Regulatory Procedures for Medical Devices Under European Directives

NIC Document

The European Union (EU) has a standard set of regulations for the development and sale of medical devices. This guide outlines the basics of European medical device legislation (focusing on the Medical Devices Directive 93/42/EEC).

In brief

  1. The process of CE marking a medical device
  2. Classification
  3. Conformity assessment route
  4. Notified bodies
  5. Meeting the essential requirements
  6. MDD Annex 1
  7. Clinical data
  8. Declaration of conformity

Introduction

Europe provides the framework onto which individual member states attach their own member laws in accordance with European Directives. The theory is that compliance with a Directive will ensure compliance with national laws - and non-compliance with the Directive will ensure non-compliance with the national laws. In reality, areas of language, parliamentary processes and national political interests can affect how Directives are applied. Harmonised standards have been developed. Complying with a harmonised standard guarantees that the essential requirements of the Directive(s) under which it was harmonised have been met. There are a range of other harmonised standards alongside the Medical Device Directives (MDD). The CE mark, visibly printed in indelible form on the device, states that the manufacturer declares the product meets all the requirements of all the applicable directives and confirms the safety and efficacy of the device.

The Process of CE marking a medical device

MDD 93/42/EEC aims to ensure that devices are designed and manufactured in a way that doesn’t compromise the clinical condition or safety of a patient and that they fulfill the manufacturer’s intended purpose. Manufacturers have to demonstrate safety, quality and efficacy before they can sell the product.

Classification

Classification is the process in which a medical device is placed into one of four risk categories, depending on the device's potential to cause harm to the patient, user or other person. This is a very important step in any compliance strategy because the classification determines the conformance route. Classification of a medical device will depend on a series of factors, including:
  • How long the device is intended to be in continuous use
  • Whether or not the device is invasive or surgically invasive
  • Whether the device is implantable or active
  • Whether or not the device contains a substance which is considered to be a medicinal substance in its own right and has an action which supports the device. As the manufacturer, you are legally responsible for correctly classifying the device, but you can ask for help from the Notified Body

Conformity assessment route

As the manufacturer, you must decide on your conformity assessment route to meet the essential requirements of the appropriate Directive. You have to make some choices as to the best route to take. These are explained in the articles of the main Directives:
  • AIMDD 90/385/EEC
  • Article 993/42/EE
  • Article 1198/79/EEC
  • Article 9. Procedures to carry out conformity assessments

You need to follow two systems:

  1. Product-related (by type examination; e.g., testing each device or a representative sample)
  2. System-related (by establishing a quality management system, e.g., ISO 13485:2003). Quality Management Systems (QMS) are the most common way of controlling product processes. ISO 13485:2003 is the QMS specific to medical devices

Notified Bodies

Notified Bodies (NBs) are the assessment organisations appointed by the Competent Authority (MHRA in the UK) who certify a manufacturer’s quality system. The level of NB involvement will depend on the classification of the product. Where an NB is used, the number of that body must appear after the CE mark, e.g. CE 0086 for BSI.

Meeting the essential requirements

As a manufacturer, you must meet the essential requirements of the Directive, regardless of classification and the conformity assessment route. You must also prove that the product meets the essential requirements. If a harmonised standard exists for the product and the product meets the standard, it is deemed to automatically meet the essential requirements. An essential requirements checklist is often useful in ensuring compliance. The checklist is frequently the crux of the Technical File and makes up an important legal document. The Technical File contains all the product development information and the evidence required by the NB for granting a CE mark. A simplified index for the Technical File is:

  1. Technical File Maintenance Policy, including notification of significant changes.
  2. Controlled Document and Quality Record retention periods
  3. Intended Purpose of Device 4. Documented Classification and Attestation Route
  4. Manufacturing and Full QA Specification
  5. Product Description, including Variants and Accessories
  6. Performance Claims + Indications / Contra-Indications
  7. Device Life defined with rationale and supporting data
  8. List of Standards applied in full or part
  9. Essential Requirements Checklist
  10. List of Design Input Specified Requirements and the Results of Design Verification
  11. Results of Risk Analysis as part of Risk Management
  12. Labelling Specification and Sample of Labelling and Control Procedures
  13. Instructions for Use
  14. Clinical Evaluation Data to support category 6 (above)
  15. Policy commitment and Procedure covering:
  16. Declaration of Conformity including Product Schedule
  17. Notified Body intervention if: Class I Sterile Device, Class I Device with a Measuring function, Class IIa or higher
  18. Registration with Competent Authority if: Class I Self Certification Custom Made Device under Article 12
  19. Appointment of an Authorised Representative and Registration with a Competent Authority if outside Europe
  20. Procedures
  21. Forms
  22. Risk Analysis Form
  23. Risk Analysis
  24. Post Sales Vigilance
  25. Post Market Feedback
  26. Product Recall
  27. Issue of Advisory Notices
  28. Complaint Handling

MDD Annex 1

MDD Annex 1 states, ‘The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients or users, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient.’ You should apply risk assessment techniques on an ongoing basis. The current harmonised standard for risk assessment is ISO 14971:2007.

Clinical data

Clinical data is crucial for backing up your claims about the device. The data can come from the following sources
  • Examine the literature that exists for similar products
  • Data collected and collated from a clinical trial meeting regulatory requirements – this is rare for Class I and II devices
  • The use of phase IV marketing trials after the CE mark is applied can be invaluable in establishing the efficacy of the product even further.

Declaration of conformity

This is the legal procedure in which the manufacturer declares that the products concerned meet the provisions of the Directive(s) which apply to them. It is signed by the manufacturer, lists the device classification and the route of conformity. The Competent Authority should be informed (e.g., the MHRA in the UK).