A wireless medical device in the EU must comply with both the MDR (EU) 2017/745 and the Radio Equipment Directive 2014/53/EU (RED). The MDR covers safety and clinical performance. The RED covers radio spectrum, electrical safety for radio equipment, and harmful interference. Two CE routes. One product. Both must close before you ship.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • Every medical device that transmits or receives radio waves (BLE, Wi-Fi, NFC, LoRa, cellular, proprietary 2.4 GHz) falls under both the MDR and the Radio Equipment Directive 2014/53/EU.
  • RED compliance is a separate CE route with its own essential requirements: Article 3.1(a) safety, Article 3.1(b) EMC, Article 3.2 efficient spectrum use.
  • MDR Annex I §14.5 requires devices to be designed to eliminate or reduce risks from electromagnetic interference, and §17 covers electronic programmable systems.
  • EN 60601-1-2:2015+A1:2021 is the EMC collateral standard for medical electrical equipment and covers immunity and emissions in professional and home use environments.
  • Testing is not free and not fast. A full RED plus EN 60601-1 plus EN 60601-1-2 campaign for a wireless wearable typically runs 8 to 14 weeks at an accredited lab.
  • Pre-certified radio modules save weeks and tens of thousands of euros but do not eliminate system-level testing.

Why this matters

A three-person startup in Graz built a Bluetooth pulse oximeter. Their hardware lead had built consumer electronics before and assumed the BLE module's CE marking covered the whole product. It did not. When they booked their EMC slot at an accredited lab, the test engineer asked for their RED technical file and their EN 60601-1-2 test plan. They had neither. Six weeks of calendar time evaporated while they assembled a test strategy, re-ran radiated emissions after a grounding fix, and rewrote their declaration of conformity to cite both directives.

Wireless connectivity is no longer optional in medical devices. Remote monitoring, PMCF data collection, software updates, pairing with phones — all of it rides on radio. And every radio link drags a second regulatory framework into scope: the Radio Equipment Directive 2014/53/EU. Founders who treat wireless as a feature rather than a regulated subsystem lose months.

What MDR actually says

MDR (EU) 2017/745 Annex I — the General Safety and Performance Requirements — addresses wireless and electromagnetic concerns in several places.

Annex I §14 covers construction of devices and interaction with their environment. §14.5 specifically requires that "devices shall be designed and manufactured in such a way as to remove or reduce as far as possible: risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts" and risks from "reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures."

Annex I §17 covers electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves. It requires that such devices be designed to ensure repeatability, reliability, and performance in line with their intended use, and that in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce risks.

Neither the MDR nor its annexes impose radio-specific requirements. The MDR assumes that radio compliance is handled under the framework that actually regulates radio equipment: Directive 2014/53/EU.

The Radio Equipment Directive 2014/53/EU applies to any electrical or electronic product that intentionally emits or receives radio waves for the purpose of radio communication or radiodetermination. Its essential requirements include protection of health and safety, an adequate level of electromagnetic compatibility, and effective use of the radio spectrum so as to avoid harmful interference.

The practical consequence: your EU Declaration of Conformity for a wireless medical device cites both Regulation (EU) 2017/745 AND Directive 2014/53/EU. You need evidence for both.

Harmonised standards that do the heavy lifting

For the MDR side, the relevant harmonised standards for a wireless electromedical device typically include:

  • EN 60601-1:2006+A1+A12+A2+A13:2024 — basic safety and essential performance of medical electrical equipment.
  • EN 60601-1-2:2015+A1:2021 — the EMC collateral standard. Covers emissions and immunity across home, professional, and special environments.

For the RED side, you need the radio-specific harmonised standards for your chosen technology (for example ETSI EN 300 328 for 2.4 GHz, ETSI EN 301 893 for 5 GHz Wi-Fi, ETSI EN 300 330 for NFC, ETSI EN 301 908 for cellular). These sit outside the MDR harmonised list and are published under the RED framework.

A worked example

A continuous glucose monitor system: a disposable sensor patch with a BLE 5.0 radio transmits every five minutes to a smartphone app. Class IIb device under MDR. Let us walk the dual compliance path.

MDR path (Annex IX full QMS plus technical documentation assessment with notified body): - QMS to EN ISO 13485:2016+A11:2021. - Risk management file to EN ISO 14971:2019+A11:2021 — electromagnetic hazards, wireless dropout, coexistence with other 2.4 GHz devices all explicitly analysed. - Electrical safety testing to EN 60601-1 including applicable collateral and particular standards. - EMC testing to EN 60601-1-2:2015+A1:2021 covering radiated and conducted emissions, immunity to RF fields, electrostatic discharge, and the wireless coexistence test (IEC 60601-1-2 clause 5.2.1.1). - Biological evaluation for the skin-contact adhesive (EN ISO 10993-1:2025). - Software lifecycle to EN 62304:2006+A1:2015 and usability to EN 62366-1:2015+A1:2020. - Clinical evaluation per MDR Article 61.

RED path (self-declaration under Annex II of the RED if harmonised standards fully apply, otherwise Annex III with Notified Body involvement): - Radio performance to ETSI EN 300 328 (2.4 GHz wideband transmission). - EMC for radio equipment to ETSI EN 301 489-1 and -17. - Electrical safety of radio equipment — this can often be covered by EN 60601-1 itself, avoiding duplication. Confirm with your test lab which standard they will cite. - RF exposure (SAR or field strength) — for a wearable touching skin, typically EN 50566 or IEC 62209 depending on frequency and distance.

The overlap matters. EMC testing under EN 60601-1-2 and under ETSI EN 301 489 can often be combined in one test campaign if you brief your lab up front. The same chamber, the same setup, different report sections. Companies that book EMC and radio as two sequential campaigns pay twice and wait twice.

Declaration of conformity. The final document cites Regulation (EU) 2017/745 (with Notified Body number and certificate reference) and Directive 2014/53/EU (with the full list of harmonised standards applied). Two frameworks. One product. One file.

The Subtract to Ship playbook

1. Decide the radio architecture before you freeze hardware. Pre-certified modules (Nordic, Silicon Labs, u-blox, Murata) ship with RED test reports for the radio front-end. Using one shifts roughly 60 percent of the RED burden onto the module supplier. You still need system-level testing, but the expensive radio conformance work is done.

2. Write a dual-compliance test plan early. Before the first prototype, list every test required under MDR (EN 60601-1 family), every test required under RED (ETSI standards for your band), and every test that appears in both. Book one campaign, not two.

3. Use the MDR risk management file as the integration document. EN ISO 14971 already requires you to analyse electromagnetic and environmental hazards. Add wireless-specific failure modes: packet loss, coexistence with Wi-Fi, pairing attacks, radio module firmware updates, regional band restrictions. Trace every hazard to a control and a test.

4. Pick a test lab that does both. Not every EMC lab is accredited for medical EN 60601-1-2 and ETSI RED standards. A lab that does both writes one combined quotation, one combined schedule, and one set of consistent reports. Ask for their accreditation scope before you book.

5. Draft the EU Declaration of Conformity on day one. Sounds absurd. It is not. The DoC is the target document. It lists every directive, every standard, every Notified Body certificate. Drafting it early exposes missing pieces while they are still cheap to fix.

6. Plan regional variants. A device that ships to the EU under RED will also face FCC Part 15 in the US, ISED in Canada, MIC in Japan, and so on. If your radio module is pre-certified in multiple regions, this becomes paperwork. If not, it becomes another test campaign.

7. Document software-driven radio behaviour under EN 62304. Any software that controls transmit power, duty cycle, band selection, or pairing logic is part of the medical device software. It falls under EN 62304 and, for connected devices, under EN IEC 81001-5-1:2022 for cybersecurity.

Reality Check

Answer honestly. One no means you have homework before ordering test slots.

  1. Do you know which MDR Annex I GSPRs apply specifically to your wireless link, and is each traced to a verification activity?
  2. Have you read the harmonised standards list for the RED that covers your specific radio band and technology?
  3. Is your radio module pre-certified under RED, or are you planning to certify the radio yourself?
  4. Does your test lab hold accreditation for both EN 60601-1-2 and the relevant ETSI EN 301 489 series?
  5. Have you performed a wireless coexistence test per IEC 60601-1-2 clause 5.2.1.1 with representative real-world RF environments?
  6. Does your risk management file (EN ISO 14971) analyse packet loss, pairing attacks, and radio module firmware update failures as distinct hazards?
  7. Is your EU Declaration of Conformity drafted, listing both Regulation (EU) 2017/745 and Directive 2014/53/EU with their respective harmonised standards?
  8. Have you costed the dual-compliance campaign including re-test contingency (20 to 30 percent of the original budget is realistic)?

Frequently Asked Questions

Do I need a Notified Body for the RED side as well as the MDR side? Not usually. If you apply harmonised standards in full under the RED, you can self-declare conformity under Annex II of the RED. If you deviate from harmonised standards or none exist for your radio technology, you need a Notified Body for the RED (Annex III route). The MDR side follows its own conformity assessment path based on device class.

Can I reuse my EMC report from RED testing for the MDR technical file? Partially. The emissions and immunity tests overlap, but EN 60601-1-2 has medical-specific immunity levels and test methods that ETSI EN 301 489 does not cover. A well-planned campaign runs both standard families in one sitting and produces reports that reference each other.

Does using a pre-certified BLE module mean I do not need RED testing at all? No. The module certificate covers the radio at the module boundary. As soon as you put it inside a housing with antennas, cables, and other electronics, system-level tests (radiated emissions, coexistence, SAR if body-worn) are required on the integrated device.

What about devices that only receive radio (like GPS)? Receive-only devices still fall under the RED. The requirements focus on protection from interference and efficient use of spectrum through receiver selectivity.

Are there specific MDR requirements for wireless cybersecurity? Yes. MDR Annex I §17.2 and §17.4 require state-of-the-art IT security measures. EN IEC 81001-5-1:2022 and MDCG 2019-16 Rev.1 are the authoritative references. Wireless attack surfaces (pairing, over-the-air updates, eavesdropping) must be in scope of your threat model.

How long does a full dual-compliance test campaign take? For a simple BLE wearable with a pre-certified module, plan 8 weeks minimum at a good lab. For anything more complex, 10 to 14 weeks, plus re-test buffer.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Annex I §14, §14.5, §17.
  2. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment (Radio Equipment Directive).
  3. EN 60601-1:2006+A1+A12+A2+A13:2024 — Medical electrical equipment — Part 1: General requirements for basic safety and essential performance.
  4. EN 60601-1-2:2015+A1:2021 — Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances.