Compassionate use & special access
Regulatory basis - MDR Art. 59 (compassionate use); MDR Art. 53 (humanitarian device exemptions via custom-made pathway); MDR Art. 62(4)(f) (compassionate use within clinical investigations); member state national provisions for named-patient / hospital exemption access.
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Access pathways vary significantly by member state — always consult the relevant national competent authority.
When special access pathways apply
These pathways allow patients to access medical devices or IVDs that have not yet received CE marking, or where a CE-marked device is unavailable, in circumstances involving:
- Serious or life-threatening conditions
- No adequate CE-marked alternative available
- Individual patient need that cannot be met by available options
Each pathway has different eligibility criteria, procedural requirements, and regulatory oversight.
MDR Art. 59 — Compassionate use
MDR Art. 59 provides a framework for member states to allow the use of specific devices that have not yet received CE marking for groups of patients with a serious, life-threatening, or chronically debilitating condition, where no CE-marked alternative exists.
Key features
- Applies to device types (not individual patient applications) — a member state may decide to allow use of a specific unapproved device in a defined patient group
- The manufacturer must be pursuing CE marking — they must have applied or intend to apply for MDR conformity assessment
- The device must be manufactured and controlled in accordance with the requirements of MDR (safety and performance)
- The NCA of the member state authorises the use
- Member states may impose additional national conditions
Difference from clinical investigation
Compassionate use is distinct from a clinical investigation (MDR Art. 62). Clinical investigations are conducted to generate evidence for CE marking. Compassionate use is therapeutic — the primary purpose is patient treatment, not data collection, although data collection may be a secondary objective.
Named-patient / hospital exemption
Many EU member states have national provisions allowing named-patient access to unapproved or unavailable devices for individual patients under the care of a specific physician. This is sometimes called the "hospital exemption" or "named-patient basis" access.
Typical requirements
- Physician prescription: the treating physician identifies a specific patient with a serious condition who cannot be treated with available CE-marked options
- NCA notification or authorisation: most member states require the physician or institution to notify or obtain approval from the NCA
- Patient informed consent: the patient must be informed the device lacks CE marking and consent to use
- Record-keeping: the physician and institution maintain records of use
Member state variation
Requirements vary significantly. Some member states have streamlined notification processes; others require detailed applications. Always check with the NCA of the relevant member state before initiating named-patient access.
Clinical investigation pathways for access
For patients who may benefit from an investigational device being studied in a clinical investigation, MDR Art. 62–82 provides a framework for access as part of the study. Patients enrolled in a clinical investigation can access the investigational device under the study protocol and GCP framework.
For patients who cannot be enrolled in an ongoing study, some clinical investigation protocols include compassionate use or expanded access arms allowing additional patients to receive the device outside formal study endpoints.
Authorised prescribers
Some member states designate authorised prescribers — specialists with specific expertise who are permitted to prescribe or use unapproved devices in their area of expertise under controlled conditions. The designation process and obligations vary by member state.
Personal importation
Personal importation of a medical device for personal use is generally permitted in the EU but is heavily regulated in practice:
- The device must be for the individual's own use (not for resale)
- Many member states restrict importation of devices requiring professional prescription or installation
- The individual assumes all risk — no regulatory oversight of the specific imported device
- Customs rules apply for devices from outside the EU
- Certain device types (implantables, Class III) present practical barriers to personal importation
Related pages
Official references
| Reference | Description |
|---|---|
| MDR Art. 59 | Compassionate use framework |
| MDR Art. 62(4)(f) | Compassionate use within clinical investigation context |
| MDR Art. 53 | Exemptions for devices used in the interest of public health |
| National NCA websites | Named-patient and hospital exemption procedures by member state |