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European harmonized standards: Beware of Annex ZA!

January 4, 2016

5 Min Read
European harmonized standards: Beware of Annex ZA!

Pharmaceutical & Medical Packaging News staff

The three EU directives for medical devices: MDD1, AIMDD2, and IVDD3, follow the concept defined as the "New Approach4" which was introduced in the 90s.

Thierry Wagner

New Approach directives include a list of mandatory 'essential requirements' designed to guarantee the protection of health and safety of users, animals, the environment, etc. Manufacturers must conduct a risk analysis to determine the applicable essential requirements on a given product and intended use. Essential requirements are formulated in a general way, leaving freedom on how to meet them so that technical innovation and the use of state of the art technology are not constraint. This makes sure that legal texts do not need to be readapted constantly with technological progress while products can evolve and stay up to date.

Essential requirements are listed in annex I of the medical directives. The New Approach has also introduced the concept of harmonized standards, which are prepared and published by European standards organizations (ESO). There are three ESOs:

  • CEN (European Committee for Standardization)

  • CENELEC (European Committee for Electrotechnical Standardization)

  • ETSI (European Telecommunications Standards Institute)

To be harmonized, the respective standards need to be published in the Official Journal of the EU, they need to be transposed into a national standard in at least one member state and they need to have an annex, called the Annex ZA, with a table, following a standard template and indicating the correspondence between the respective European standard and the medical device directive.

Annex ZA details which essential requirements or parts of essential requirements of the MDD are covered. The harmonized standards may be European developed standards, but they can also be international or national standards that get adopted as EN standards. EN ISO 11607 -- "Packaging for terminally sterilized medical devices"5,6 for example, is the harmonized standard for medical packaging, which is an ISO standard that has been adopted as an EN standard. It is important to note, that harmonized standards always maintain their voluntary nature, their application however gives presumption of conformity with the respective essential requirements, conformity which has to be demonstrated individually if a manufacturer decides to follow an alternative route to comply with the essential requirements.

Click here for the list of harmonized standards for the medical device directives.

Recently, the EU commission has put more attention and scrutiny on the Annex ZA of harmonized standards. A number of standards now have gaps or deviations clearly identified where they do not completely fulfil the essential requirements. It is important that manufacturers review the Annex ZA of harmonized standards to identify any gaps and deviations. It is expected that risk management reports and essential requirements check lists include separate compliance documentation for those gaps and deviations of the standard.

An example in this context is the new Annex ZA of EN ISO 14971 on the application of risk management published in 20127, while the content of the standard itself did not change. When mitigating risks, it is no longer possible to apply the concept of "ALARP" (as low as reasonably practical, in other words introducing economic aspects), but the risk level must be reduced "as far as possible". Furthermore, it is no longer possible to reduce risk solely by adding a label or warning on the instructions for use. Applying a "do-not-use-in-case-of-damage" label is still valid, but it cannot be used to mitigate the risk of a weak packaging design.

These are important changes within an Annex ZA that will certainly have also an impact on the design and the validation of medical packaging. Make sure to review annex ZA of harmonized standards, more deviations and gaps are expected to emerge in the future.

References:

1, Council and European Parliament, COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) amended by: Directive 98/79/EC of 27 October 1998, Directive 2000/70/EC of 16 November 2000, Directive 2001/104/EC of 7 December 2001, Regulation (EC) No 1882/2003 of 29 September 2003, Directive 2007/47/EC of 5 September 2007. 2007.
2. Council, COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) as amended by Council Directive 93/42/EEC of 14 June 1993, Council Directive 93/68/EEC of 22 July 1993, Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 and by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (consolidated version). OJ, 1990. L 189.
3. Council and E. Parliament, DIRECTIVE 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices as amended by Regulation (EC) No 1882/2003 of 29 September 2003, Regulation (EC) No 596/2009 of 18 June 2009 and by Commission Directive 2011/100/EU of 20 December 2011. OJ, 1998. L 331.
4. Commission, E., Guide to the implementation of directives based on the New Approach and the Global Approach, 1999: Brussels.
5. International Organization for Standardization, ISO 11607-1:2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems, 2006, ISO: Geneva.
6. International Organization for Standardization, ISO 11607-2:2006 Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes, 2006, ISO: Geneva.
7. European Committee for Standardization, EN ISO 14971:2012 Medical devices -- Application of risk management to medical devices, 2012, CEN: Brussels.

Stay relevant as a medical device packaging engineer 

Thierry Wagner, Regulatory Affairs Director, EMEA

 

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