Product compliance legislation is always changing, but one thing remains the same: companies need to comply with looming deadlines. While there is almost always good cause to refresh your data sendouts, high-quality data is essential to support compliance with your regulatory requirements now and in the future. Companies need to be aware of new legislation, as well as updates to existing legislation, in order to ensure they are prepared to comply.

The list of updated and new legislation includes:

  • Regular expansions to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation and California Safe Drinking Water and Toxic Enforcement Act (Proposition 65) substance lists.
  • Expiring European Union (EU) Restriction of Hazardous Substances (RoHS) Directive exemptions.
  • Implementation of new EU RoHS phthalate restrictions in the medical devices industry.
  • The EU Waste Framework Directive (WFD) and the Substances of Concern in Products (SCIP) database.
  • The EU Medical Device Regulation (MDR).
  • Teflon and perfluorooctanoic acid (PFOA, or C8) bans.

In particular, companies should note that manufacturers must find an alternative to perfluorooctanoic acid (PFOA). In November, the European Commission put forward a proposal to tighten the Regulation (EU) 2019/1021 on persistent organic pollutants (POPs) to reflect the substance’s listing in the Stockholm Convention.

Here is a look at some other upcoming product compliance deadlines.

Submitting to the SCIP Database

Companies are working hard to meet the January 5, 2021, SCIP database submission deadline. As a requirement of the updated EU Waste Framework Directive (WFD), companies must collect an additional set of data fields, include it with data on REACH substances of very high concern (SVHC), package it in the IUCLID format, and submit it to the database.

In February, the European Chemicals Agency (ECHA) released its Programming Document(s) 2020-2023. The strategic plan outlines its vision both for the release of the database, and ongoing revisions to the data fields required by the legislation. With an annual budget of more than 2 million euros, this shows that the agency intends to continue investing in maintaining the database, and companies will need to continuously update their substance data and submission dossiers as a result.

RoHS 3 & Medical Devices

Since restrictions on four new substances came into effect under the EU RoHS Directive on July 22, 2019, medical devices companies have had an additional two years to prepare for compliance, but time is almost up. Medical device companies must demonstrate compliance with these restrictions by July 22, 2021. These substances are:

  • Bis(2-ethylhexyl) phthalate (DEHP)
  • Benzyl butyl phthalate (BBP)
  • Dibutyl phthalate (DBP)
  • Diisobutyl phthalate (DIBP)

EU Medical Device Regulation

The deadline for compliance with the EU Medical Device Regulation is May 26, 2021, a date that reflects the 12-month extension approved in April following a formal request from MedTech Europe. The EU In Vitro Diagnostics Regulation comes into effect on May 26, 2022. Despite lingering questions surrounding the deadline change, companies in scope must ensure they are proactively gathering substance data and preparing their technical files in advance of these dates.

Assent Helps You Stay Prepared

Companies need to start acquiring any missing data now to maintain EU market access and reduce the risk of non-compliance. The Assent Compliance Platform helps companies mitigate a variety of risk, automate and centralize data management, and stay ahead of changing regulatory requirements.

For more information about how Assent’s experts can help you maintain EU market access, contact us today.

James Calder
SVP, Strategic Channels & Corporate Development

James leads the Corporate Development function at Assent, creating and executing on strategies to increase strategic partnerships and channel sales, and identify growth opportunities through mergers  Read More

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