Rohs Compliance For Medical Devices In The Eu

Scope and evidence must be confirmed before any paid tests or filings.

RoHS compliance for medical devices is a separate EU chemical-restriction decision, even when the device is also assessed under the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR). A CE mark or a medical-device certificate alone does not establish which homogeneous materials meet RoHS limits.

Work from the exact model, intended electrical function, first EU placing-on-market date and material-level evidence. The question is not simply whether the product is called “medical”.

Which medical products actually fall under EU RoHS?

Directive 2011/65/EU covers electrical and electronic equipment (EEE), including medical devices in Annex I category 8. EEE needs current or electromagnetic fields for at least one intended function and meets the Directive’s voltage definition. The Article 2(4) exclusions must be assessed against the actual product, not assumed from its clinical setting.

Product situation	Initial RoHS route	Fact still needed
Powered patient monitor, infusion pump or imaging console	Usually category 8 medical EEE, if its intended functions and electrical ratings fit	Model boundary, supply ratings, complete device and accessories
Powered in-vitro analyser	IVD EEE is covered; specific start date differs from other medical devices	IVD status, first EU placement date, instrument versus consumables
Active implantable medical device itself	Express exclusion: Article 2(4)(h)	Whether the product is genuinely an active implantable device
Separate charger, bedside monitor or programmer for an implant	Do not automatically extend the implant exclusion to this separate EEE	Independent intended function and product scope
Passive catheter, dressing or non-electrical consumable	Not EEE merely because it has a medical purpose	Whether any electrical function is integral to the marketed item

Research-only equipment sold solely business-to-business and large-scale fixed installations have separate, narrowly defined exclusions; neither follows just from a hospital or laboratory location. If a product contains several separately marketed units, screen them individually.

What are the ten limits and when did they apply to medical devices?

Article 4 and Annex II restrict concentration by weight in each homogeneous material, not by average weight of the finished device. A polymer cable jacket, a solder joint and a surface coating may therefore each require their own evaluation.

Group	Substances and maximum level in each homogeneous material	Medical-device dates
Original six	Lead, mercury, hexavalent chromium, PBB and PBDE: 0.1% each; cadmium: 0.01%	Medical devices: 22 July 2014; IVD: 22 July 2016
Four phthalates	DEHP, BBP, DBP and DIBP: 0.1% each	Medical devices including IVD: 22 July 2021

These are restriction start dates for the relevant equipment placed on the EU market, not a blanket prohibition on all servicing of older models. The special cable/spare-part provisions and current exemptions still require separate analysis.

For these start dates and any legacy repair route, record when the individual physical unit was first placed on the EU market—not when the model or product family first launched. A 2026 unit of a model originally launched in 2015 does not acquire the 2015 unit’s transitional status. ‘Placing on the market’ is a unit-specific event; later distribution of a unit already placed on the market is a different step (Commission Blue Guide 2022).

Separate phthalate spare-part rule: Annex II does not apply the DEHP/BBP/DBP/DIBP restriction to cables or spare parts used to repair, reuse or upgrade medical or IVD devices placed on the market before 22 July 2021. This is a restriction-specific exception, not an exemption for the other six substances.

Medical exemptions and older equipment: choose the correct legal branch

An exemption is application-specific, not a blanket exemption for “medical equipment”. Article 4(6) points to Annex III and the medical/monitoring-specific Annex IV. Record the entry number, restricted substance, precise technical use, product category, expiry and current renewal or delegated-act status before relying on it.

Situation	What to verify	Unsafe shortcut
New device whose homogeneous material exceeds a RoHS limit	Exact Annex III or IV entry, application conditions and live legal status; or redesign the material	Quoting an old numbered exemption with no status check
Repair or upgrade of an older device	Article 4(4), the pre-2014/pre-2016 placement date as relevant, and Annex II’s special pre-2021 phthalate rule for cables/parts	Assuming every newly sold part is unrestricted because the original device is old
Recovered component reused in a refurbishment	Article 4(5) source/destination dates, auditable closed-loop B2B return system and customer notification; consider any separate valid Annex IV entry	Treating recovered parts as a universal open-market exemption

Critical 2026 cut-off: the particular Article 4(5)(c) closed-loop reuse route for parts recovered from IVD placed on the market before 22 July 2016 required the destination EEE to be placed on the market before 22 July 2026. That deadline has passed as of October 2026. Do not rely on this route for new placements now; assess Article 4(4), other narrow provisions or currently valid exemptions independently.

The 22 July 2026 condition concerns the placing-on-market date of the receiving EEE, not the calendar date on which a repair is performed. A qualifying part may still be reused after that date in an eligible receiving unit already placed on the market before the cut-off, but only if all Article 4(5) origin, closed-loop and notification conditions are proved. A device newly placed on the market from 22 July 2026 cannot use this particular branch.

A different, application-specific route remains important after that 2026 cut-off: Annex IV entry 47 covers DEHP, BBP, DBP and DIBP in spare parts recovered from and used for repair or refurbishment of medical devices (including IVDs) and their accessories, provided reuse occurs in an auditable closed-loop business-to-business return system and each reuse is notified to the customer. Its stated expiry is 21 July 2028. Check the exact entry and any later amendment or renewal before use; it does not exempt lead, cadmium or other substances, or automatically legalise new equipment.

A timely renewal request can keep an existing exemption valid while a Commission decision is pending; an application for a new exemption does not make non-compliant goods marketable meanwhile. Verify the current EUR-Lex text and the Commission/ECHA exemption records, especially where a printed expiry date has passed.

The seven-part RoHS evidence file for a medical-device model

The manufacturer is responsible for a reasoned conformity file under RoHS Article 7 and internal production control (Module A). Organise the technical documentation around the actual build, not a generic “RoHS compliant” statement.

Product identity: legal manufacturer, model/revision, intended function, electrical rating, EU market scope and applicability/exclusion decision.
Controlled bill of materials: electronics, solder, cables, plastics, coatings, adhesives, replaceable modules and high-risk homogeneous materials.
Supplier evidence: dated, part-number and revision-linked material declarations; substance coverage must include all ten restricted substances.
Risk assessment: identify potential lead-bearing alloys, cadmium pigments, flame retardants and DEHP/other phthalates in flexible polymers.
Verification: evaluate supplier reliability and use appropriate targeted tests where declarations or material information are insufficient; identify test method and sampled material.
Exemption register: precise Annex entry, affected part, supporting design evidence, validity/renewal decision and alternative-material review.
Release and change-control record: RoHS declaration evidence, applicable EU DoC references, revision approval, retention and recheck triggers.

EN IEC 63000:2018 is a harmonised standard for compiling this technical evidence, as cited in Commission Implementing Decision (EU) 2020/659. A standard is not a separate law, and neither blanket testing of every component nor mandatory independent “RoHS certification” follows simply from the Directive. Unsupported supplier claims may nevertheless require testing.

Who signs off RoHS when MDR or IVDR also applies?

RoHS applies alongside, not instead of, MDR/IVDR. The manufacturer must demonstrate Article 4 compliance, retain RoHS documentation and declaration for ten years after placing the equipment on the market, and control serial production. The medical-device notified body, where required by MDR/IVDR, does not automatically issue a separate compulsory RoHS certificate.

Operator	Core RoHS decision or check
Manufacturer	Establish applicability and substance evidence; carry out Module A or an eligible at-least-as-stringent process; draw up declaration and affix CE marking when applicable.
EU importer	Before placing third-country EEE on the market, check conformity assessment, technical documentation, CE marking and required identification/documentation; act on suspected non-conformity.
Distributor	Exercise due care over markings and supplied documentation; do not make suspected non-conforming EEE available.

If a device is subject to MDR and RoHS, MDR Article 19(2) calls for a single EU declaration of conformity covering applicable acts; IVDR Article 17(2) provides the analogous rule. Identify the legislation and satisfy each declaration’s content requirements. Rebranding or material modification can shift RoHS manufacturer obligations to an importer/distributor (Article 11).

A five-step release gate for a new or changed medical device

1. Freeze the exact model and intended functions; classify medical EEE/IVD, active implant, passive part or another Article 2 exclusion.
2. Date the EU placing-on-market event and distinguish a new device from the repair, replacement or recovery of an older one.
3. Map the ten substances against homogeneous materials and trace missing supplier evidence to the exact part revision.
4. If a homogeneous material exceeds a legal substance limit, document an exact current Annex exemption or applicable legacy exception; otherwise redesign or hold release.
5. Approve the technical file and relevant combined EU declaration, then set change triggers for suppliers, resins, solder, cables, manufacturing sites and legal exemption status.

Changes intended to remove a restricted substance can affect clinical performance or device reliability. Reassess relevant MDR/IVDR safety and performance consequences rather than treating the material substitution as a purely environmental edit.

A legacy spare-part allowance cannot be used to place a newly manufactured medical device on the market merely because the design resembles an older model. Establish whether the transaction is genuine servicing of eligible previously placed equipment or a new placement, then apply the correct branch.

Three practical traps in medical-equipment projects

A patient monitor with a CE-marked housing: CE marking does not prove the phthalate concentration of its flexible cable insulation; link material declarations or targeted test evidence to the cable revision.
An X-ray device containing lead: an Annex IV reference may be relevant to a specified X-ray application, but it does not excuse unrelated lead-containing solder or plastic; verify the exact entry and status.
A 2015 IVD analyser being refurbished in 2026: the old machine’s date is only the starting fact; the kind of spare part, reuse route and dates decide whether a transitional rule helps.

These are decision illustrations, not legal determinations for an unidentified product. A supplier PDF lacking an item identifier, substance list or revision is a material evidence gap.

What to assemble before requesting a RoHS compliance review

Prepare the product/variant list, classification rationale, model labels, first EU placement dates, BOM with supplier contacts, ten-substance evidence, planned exemptions and any repair/reuse history. The immediate safe action is a part-level gap assessment and a documented release decision; do not infer permission from a CE logo or an expired exemption number.

For adjacent tasks, see EU medical-device CE conformity route; IVDR conformity services; EU RoHS testing and evidence services.

Medical-device RoHS: specific questions

Does an MDR or IVDR CE certificate automatically prove RoHS compliance?

No. The clinical regulatory route and RoHS material restrictions are distinct. Where both apply, the manufacturer must substantiate each; an appropriately completed single EU declaration can identify both instruments.

Must non-electrical single-use medical consumables meet RoHS?

Not merely because they are medical devices. Determine whether the marketed article is EEE under Article 3 and whether a separate electrical unit or accessory is supplied.

Does the RoHS exclusion for an active implantable device cover its external programmer?

Not automatically. Article 2(4)(h) excludes active implantable medical devices; independently marketed external electrical devices require their own scope analysis.

May an old IVD analyser be serviced with non-RoHS-compliant or recovered parts?

Possibly under particular Article 4(4) or 4(5), Annex II cable/part or valid Annex IV rules. Verify original market date, source and destination of the part, repair versus new sale and any closed-loop/notification conditions before relying on an exception. For the four phthalates in recovered parts, separately check Annex IV entry 47 (stated expiry: 21 July 2028).

Does an Annex IV lead exemption for radiology equipment allow lead throughout the whole device?

No. The relevant exemption concerns a defined material and application and is subject to scope, dates and current legal status. Other lead-containing homogeneous materials must independently comply or qualify for a different valid exemption.