Tag: Medical Device Directive

93/42/EEC – The Medical Device Directive and it’s Harmonized Standards

When Medical Device companies do business in Europe, they are required to conform to the EU’s Medical Device Directive, 93/42/eec.  One important way to comply is to use the applicable standards from the Harmonised List for Medical Devices.

What is a European Directive?  It’s a legislative act, rather than a regulation, that requires a specific outcome but does not dictate how that outcome is to be achieved.  Countries are given a specific timetable for conformance with the directive.    The Treaty that created the functioning of the  European Union states,  “A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods.”

With the adoption of the New Approach methodology for directives, there is the ability to create a directive that is not based on specific limits or tests, but on “essential requirements.”  This allows for the European market itself, through the mechanism of the EN Standards, to set the details of limits and tests rather than through specific language in the directive itself.

So for a limited number of directives, there are lists of Harmonized Standards that define the requirements for each.  These European Standards are created at the regional level and then adopted as national standards in each member country.  However, the standards are not mandatory — their use is still considered voluntary.  So in principle an alternative means of proving compliance with the safety requirements of the directives is possible.

This is the case with the Medical Device Directive, 93/42/eec.  The MedDev List of Harmonized Standards provides the easiest way to meet the requirements of the directive.

One last question to answer — How are directives amended?  Due to the way in which directives are generated, it takes a directive to modify a directive.  So 93/42/eec has been amended 5 times, by 98/79/EC, 2000/70/EC, 2001/104/EC, 2003/32/EC, and 2007/47/EC.  Luckily, there is a consolidated reprint of the Medical Device Directive, issued in 2007, that consolidates the original text with these 5 amendments.

The Directives and European Standards are all available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (+650-591-7600), fax (+650-591-7617) or email (info@document-center.com).  Our expert staff is available Monday through Friday, 8 am to 5 pm California time, to help you with your Standards needs.

EN 1041 (aka BS EN 1041) on Information supplied by the manufacturer of medical devices critical for medical device manufacturers

The EN 1041 (normally sold as BS EN 1041, the official English language edition) is the European requirement for information supplied by the manufacturer of medical devices.   Frequently ordered by Document Center Inc. customers, the standard is part of the harmonized documents for the Medical Device Directive (93/42/EEC).

BS EN 1041 Information supplied by the manufacturer of medical devices

BS EN 1041 specifies the requirements for information to be supplied by a manufacturer, for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied.

BS EN 1041 is intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on the way that the requirements can be met. If a manufacturer follows BS EN 1041, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.

This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards.

When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

Why has BS EN 1041 been revised?

BS EN 1041 has been revised to take account of changes in the Directives applicable to medical devices.

Since the time of approval of the first edition of this standard on 18 January 1998, the Medical Device Directive (MDD) (93/42/EEC) and Active Implantable Medical Device Directive (AIMDD) (90/385/EEC) have been amended. In addition, new methods of provision of information have become freely available and widely used.

The new edition is intended to make available guidance for manufacturers of medical devices that is appropriate regardless of the means used to disseminate that information and it is intended that it should, as far as possible, be suitable for future methods of provision of information.   In this standard, Directives 90/385/EEC and 93/42/EEC refer to the versions amended in 2007.

The requirements and guidance will provide manufacturers with appropriate means to ensure that their provision of information is relevant to all intended recipients and is in compliance with the Essential Requirements of the Directives. The requirements may also provide means by which compliance can be tested by regulatory and inspection agencies.

The possibility of providing information by alternative means is foreseen in Directives 93/42/EEC and 90/385/EEC and guidance on alternative labelling is provided.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives 93/42/EEC and 90/385/EEC, as amended.

Practical guidance about the implementation of the essential requirements of the applicable Directives is included.

The relationship with EU Directives, (which are integral parts of this document) are also covered.

Contents of BS EN 1041 include:

  • Introduction
  • Scope
  • Normative references
  • Terms and definitions
  • Requirements
  • Units, symbols and colours
  • Language and country identifiers
  • Dates
  • Device nomenclature
  • Identifiers of nomenclature
  • Device common terms
  • Batch code; lot number; batch number; lot code
  • Requirements for provision of information
  • Specific requirements
  • Applicability
  • Accessibility
  • Legibility
  • Availability
  • Security
  • Changes to information provided
  • Documentation
  • Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended
  • Requirements and guidance for medical devices (Directive 93/42/EEC)
  • Requirements and guidance for active implantable medical devices (Directive 90/385/EEC)
  • Guidance on alternative labelling for instructions for use (IFU)
  • Guidance on alternative labelling for medical devices (Directive 93/42/EEC)
  • Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC)
  • Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC
  • Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EC
  • Bibliography

BS EN 1041:2008 replaces BS EN 1041:1998 which remains current.  Both editions of the standard are available from Document Center Inc. at www.document-center.com or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Should you have any questions about the document or about standards and regulations, please contact us.