EU RoHS for medical and monitoring equipment

Directive 2011/65/EU lists category 8 as medical devices and category 9 as monitoring and control instruments, including industrial monitoring and control instruments. Category alone does not settle scope. The product must first be EEE within the Directive: equipment dependent on electric currents or electromagnetic fields to fulfil at least one intended function and designed for use at no more than 1,000 volts AC or 1,500 volts DC. Article 2 exclusions must then be checked; active implantable medical devices are expressly excluded, as are several other product groups such as equipment necessary to protect Member States' essential security interests and equipment specifically designed and installed as part of excluded equipment. The latter must function only as part of that equipment and be replaceable only by the same specifically designed equipment.

For in-scope equipment, the restriction in Article 4(1) applies by subcategory date. Identify whether the product is a general medical device, an in vitro diagnostic medical device, a general monitoring or control instrument, or an industrial monitoring and control instrument before choosing the date.

The core substance restrictions apply to medical devices and general monitoring and control instruments placed on the market from 22 July 2014, in vitro diagnostic medical devices from 22 July 2016, and industrial monitoring and control instruments from 22 July 2017. Products outside old RoHS scope but inside RoHS 2 had a separate open-scope date of 22 July 2019, unless a more specific category 8 or 9 date applied.

The four phthalates added by Delegated Directive (EU) 2015/863 have their own timing for this equipment family. DEHP, BBP, DBP, and DIBP restrictions apply to medical devices, including in vitro medical devices, and to monitoring and control instruments, including industrial monitoring instruments, from 22 July 2021.

Spare parts need a dated analysis rather than a blanket exemption. Annex II excludes the four phthalate restrictions for cables and spare parts used for repair, reuse, updating, or capacity upgrading of medical devices and monitoring and control instruments placed on the market before 22 July 2021. Article 4 also contains older category-specific spare-part provisions for the six original RoHS substances and reused parts in auditable closed-loop business-to-business systems.

Medical and monitoring equipment may use ordinary Annex III exemptions where the entry applies, and may also use Annex IV entries that are specific to medical devices and monitoring and control instruments. Those entries are application-specific, not company-wide or product-wide. A compliant record should therefore identify the exact material or component, restricted substance, exemption entry, category, expiry date, and renewal status.

Annex IV includes entries for applications such as ionising-radiation detectors, X-ray tubes, MRI-related uses, electrochemical sensors, industrial monitoring sensors, recovered spare parts, and certain DEHP uses. The entries do not share one expiry date, and an old date in the Annex does not by itself show that a renewal is pending or that the exemption remains usable. Check the exact consolidated entry, the Commission's current exemptions list, and any renewal decision for that entry before release.

For category 8 and 9 products, the evidence file should let a reviewer trace the classification, date decision, restricted-substance assessment, exemptions, supplier inputs, and CE declaration without relying on project memory. Manufacturers must draw up technical documentation, complete the conformity assessment route, draw up the EU declaration of conformity, affix the CE marking on finished EEE, and keep the technical documentation and declaration for 10 years after placing the EEE on the market.

EN IEC 63000:2018 is the harmonised standard reference published for RoHS technical documentation. It supports a structured evidence set for materials, components, and EEE; it does not supersede the need to map the specific device, instrument, spare part, supplier declaration, lab test, or exemption to the exact RoHS requirement.