Harmonised standards Theory

What are harmonised standards?

When we talk about harmonised standards, we mean European standards developed by a recognised European Standard Organisation. Recognised Standard Organisations are CEN, CENELEC, or ETSI. They create harmonised standards at the request of the European Commission.

Who are the members of CEN?

CEN members elect to use the EN Standard without technical changes. For medical devices and in vitro diagnostics this is mostly the case. Because no national technical boundaries make sense.

What is the difference between an International and European Standard?

The difference between a European standard (e.g. EN ISO) and an international standard (e.g. ISO) are

  • the European foreword and
  • the informative Annexes ZA, ZB and so on.
Difference between International and European Standards

European standard organizations write the European foreword and Annex(es), both of which are informative. The Annexes ZA describe how the European standard(s) and European directives correspond to one another.

What is a national standard?

European standards aren’t available for sale. National Standard Organizations publish European Standards as national adoptions. In Switzerland the SNV publishes a standard as SN EN ISO or IEC. The SNV and other National Standard Organizations don’t alter the technical requirements of European Standards. There are cases where national requirements are added to the Annex but, for medical devices and in vitro diagnostics, no national requirements are added. The European part of the standards is the same in all countries participating in European Standard Organizations.

Path from international standard to list of applied standards and regulations

Why should a manufacturer be interested in harmonised standards?

A manufacturer can demonstrate compliance with the requirements of an EU regulation by applying harmonised standards. It is much easier to follow the suggested requirements of a standard than it is to generate requirements using the regulatory source.

How can I find harmonised standards?

When nothing changes, it is quite simple to find applicable harmonised standards:

  • Go to the website of the European commission
  • Choose the regulation you want to comply with
  • Select the harmonised standards that apply for your type of service or product

Where can I purchase harmonised standards?

Since European Standard Organizations don’t publish European Standards, manufacturers must buy standards from an official standard organization, such as SNV. The standard’s meta data indicate the correlation to the European Standard.

See 13485 as an example.

How do I find harmonised standards for medical devices and in vitro diagnostics?

For companies complying with Medical Devices Regulation (MDR) and in vitro diagnostics regulation (IVDR), it is quite difficult to find the applicable harmonised standards. This is because harmonised standard lists to support IVDR and MDR are not ready.

On 15.05.2020 the European Commission requested CEN and Cenelec to harmonise standards to support IVDR and MDR. There is a standard list with planned adoptions, see attachment. The due dates are staggered through to 27 May 2024. There are many fewer standards on this list than for the Medical Devices Directive (MDD).

The current lists of MDR standards aren’t completed yet, but the MDR is in force. Therefore, the European Commission has decided that compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements. Where the essential requirements are defined in MDD’s Annex I and the MDD harmonised standards are a way to demonstrate compliance with essential requirements.

What is the best Practice?

Best practice is to choose standards with priority from the MDR (EU) 2017/745: harmonised standard list and the missing ones from the MDD 93/42/EEC or active implantable 90/385/EEC harmonised standards list.

Companies can apply the same strategy for in vitro diagnostic medical devices. The list of IVDR harmonised standards still is emerging. Hence, choose from the IVDR list first.

Compliance with all European Regulations

Standards are a great way to demonstrate compliance with a regulation and state of the art. Moreover, they include a lot of examples and know-how. However, interpretation of standards and regulations is difficult and time consuming.

This is why ColabON helps with standard interpretation. To do so we present standards and regulation in a resolution ready for interpretation. If you have a standard or regulation previously assessed, we can show the old and new revision in the impact analysis.