What is the future of harmonized standards?

Nele Zgavc, BSI Group 

For national standards bodies, 2018 brings a big challenge as we aim to generate appropriate revisions of key standards that manufacturers use to show compliance to essential requirements. These harmonized standards include an Annex ZA/ZZ which represents the correlation between the requirements in the EU Medical Devices Directives (MDD, AIMD, IVDD) and the standard in question.

Now that we are moving towards the EU Medical Devices Regulations EU 2017/745 and the IN-Vitro Diagnostic Regulation EU 2017-746 (MDR & IVDR), the technical committees are reviewing their portfolio to establish what technical changes are required and also consider the new Annex ZA/ZZ. The template for the new Annex ZA/ZZ was agreed by CEN/CENELEC and the European Commission (EC) earlier this month. This is an important tipping point as the technical committees can now, in principle, start drafting the necessary changes.

However, in order for a standard to be officially recognized by the EC, for conformity purposes, an official standardization request (SR) is required. In this request, the EC set out the topics that need standardization to assist manufacturers with specifications. Given that the EC has to review each revised standard against the General Safety & Performance Requirements, it’s unrealistic to expect that this will be achieved within one year. Therefore, the EC has decided to split the SR.

The first request would only include the key horizontal and vertical standards, followed with other requests later on. All relevant technical committees have been consulted to provide their key standards for inclusion. This collated list included approx.140 medical device standards, 39 IVD standards and 7 new areas for standardization. This collation is currently being reviewed by the Medical Device Coordination Group at the EC. It’s not clear how many or which standards will be included in the first SR. There has been an indication from the commission that due to the lengthy process of the request, the SR won’t be ready until early 2019.

Having said this, this should not hinder the technical committees from revising their relevant standards and prepare the Annexes ZA/ZZ in anticipation of the SR. The aim is to create a fast turnaround of publications as soon as the request is received.

As you may already know, there have been many concerns with the non-citation of revised harmonized standards. In order to avoid a similar problem during the transition, more clarity will be given to the technical committee on drafting harmonized standards and a timeframe will be reviewed to create a phased approach for the publications.

Earlier this month, CEN/CENELEC organized a webinar together with an EC representative to discuss common mistakes in the drafting of an Annex ZA/ZZ. Bringing all parties together in this manner will hopefully be one step towards more clarity and a more productive working relationship between the two. In the coming months, we will continue to learn more about the intentions of the EC and how we can proceed with the revisions much anticipated by industry.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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