The quick answer to this question is a harmonized standard (or “harmonised” standard in EU regulations), “means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonization legislation”1.
While this sheds some light on the title question, in this post, I will answer in a bit more detail to provide you with a clearer picture of what are harmonized standards under EU MDR and EU IVDR. I’ll also include some information about the role of harmonized standards under EU MDR2 and EU IVDR3 and their importance as part of the CE conformity assessment process for medical devices or in vitro diagnostic medical devices.
Important Note
While the details of the CE conformity assessment process are beyond the scope of this post it is important to understand that demonstrating conformance with harmonized standards is sufficient to provide the presumption of compliance with specific General Safety and Performance Requirements (GSPRs). Showing conformity with GSPRs is a prerequisite to a medical device being CE Marked which highlights the importance of harmonized standards.
What is a harmonized standard?
A good starting point to understanding harmonized standards is to look at how the term harmonized standard and other categories of standards are defined within the Official Journal of the European Union.
Regulation (EU) No 1025/2012, Article 21 states the following definitions shall apply:
“(1) ‘standard’ means a technical specification, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following:
(a) ‘international standard’ means a standard adopted by an international standardisation body;
(b) ‘European standard’ means a standard adopted by a European standardisation organisation;
(c) ‘harmonised standard’ means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation;
(d) ‘national standard’ means a standard adopted by a national standardisation body;”
As you can see a harmonized standard is a European standard that has been given a special harmonization status by the European Commission and may be used to demonstrate conformity to specific GSPRs as part of the conformity assessment process.
What is the process for harmonizing a standard?
From a process standpoint, often a European standardization organization will collaborate with an international standardization body (e.g., ISO) and a standard will be published as a dual EN/ISO standard. The next step is for a European standardization organization to review it and confirm it is sufficient to demonstrate conformity with one or more of the GSPRs. Finally, a reference to the standard must be published in the Official Journal of the European Union which officially harmonizes it.
Is conformance to harmonized standards a requirement?
Of note, in the definition of “standard” above, the European Commission clarifies that compliance with a particular standard, including harmonized standards, is not a requirement. The EU MDR and EU IVDR allow the use of non-harmonized standards or standards developed in-house. However, the manufacturer will need to justify the use of these alternatives and should expect and be prepared for additional questions by notified bodies as part of the conformity assessment process.
Where do you find a list of harmonized standards?
If you’re looking for a list of harmonized standards the place to go is the European Commission website which maintains lists of harmonized standards published within the Official Journal of the European Union which I have linked here for Medical devices and In vitro diagnostic medical devices.
Summary
In summary, harmonized standards are usually the first choice for demonstrating conformity to GSPRs as part of the CE Marking conformity assessment process but other methods are acceptable. These alternative methods come with the additional burden of justifying the approach sufficiently demonstrates conformance to GSPRs.
References:
- REGULATION (EU) No 1025/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council
- REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU