Current Legislative Changes Relating to Medical Devices – Overview Summary in a Nutshell

Prescribing MD by Nurses

The ability for nurses to prescribe MD opened up in the Czech Republic in January 2022, when the amendment to Act No. 371/2021 Coll., on public health insurance, came into effect, introducing two new specialties for MD prescribers. These include 2 groups of nurses:

• Nurses in medical fields (NMF) – the prescribed MD must relate to the specialty of the physician who employs the nurse. 
• Nurses in home care (NHC) – prescribing MD is defined by the extent of delegation specified by the attending physician in the home care recommendation (delegated prescription). 

NHC and NMF thus join medical specializations as new categories for „prescription restrictions“.

A general or pediatric nurse with specialized or specific professional competence may prescribe MD. To obtain specialized competence, one must pass an attestation exam at an accredited facility and obtain a diploma in the relevant field. Specific professional competence is obtained after completing a certified course and is documented by a certificate.

MD prescribed by a nurse remains within the budget of the specific healthcare provider, and the approach of health insurance companies in controlling MD prescriptions remains unchanged. In the case of home care agencies, the prescription is charged to the delegating physician. 

Nurses can prescribe the entire group 02 MD for incontinent patients; from group 01 (covering materials), only certain MD including selected means for moist wound care are allocated to nurses. In group 03 MD for stoma patients, legislative adjustments will still be needed for nurse prescription. 

EU Regulation on Medical Devices in Clinical Practice

The new European regulation on MD (MDR) came into effect in May 2021, replacing the original directive from 1993. It represents a rather revolutionary change that tightens MD regulations primarily for manufacturers. Some MD manufacturers have stopped importing their products into the EU, as they are unable or unwilling to comply with these stricter conditions.

Healthcare facilities should verify that the given MD has an EC certificate and a declaration of conformity with the processes of European legislation and ensure the usability of existing equipment, including servicing, revision, calibration, or storage. 

Conversely, training for staff, which was previously mandatory for all class IIb and III MD, is now only required if stipulated by the MD manufacturer. The purpose of use for each MD should be defined in its instructions for use. If the MD is used contrary to its intended purpose, it is legally considered off label use. The law further mandates recording the use of class IIb or III MD or off label use in medical documentation and addressing any compromised packaging of MD if it may affect safety or efficacy. As part of MD vigilance, healthcare providers now only report serious adverse events.

Prescribed Medical Device as Hazardous Waste

In the Czech Republic, a new waste act came into effect in 2021, based on the EU regulation, and guaranteed by the Ministry of the Environment of the Czech Republic.

From a legislative perspective, needles and lancets, as sharp objects, are considered hazardous waste regardless of their other characteristics. For diapers and stoma equipment, the stance is that if they are not from an infectious patient, they can be considered standard waste.

Since the healthcare provider is the generator of waste when providing healthcare services, the healthcare professional who prescribes the MD should also ensure its disposal. According to another interpretation of this part of the law, used medications should be returned to pharmacies because the entity providing the care is the specific pharmacy that issued the MD to the patient, which aligns with current practice.

In the case of home care, the home care agency is the waste generator and should ensure its disposal. At the same time, it has the obligation to instruct the user/patient on the handling of the MD after its use and to record this information in their medical documentation.

Stoma equipment needs to be clearly categorized into a specific waste category. In standard practice, a stoma patient currently handles their used equipment as regular non-infectious waste. 

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Source: Zahálka J. Legislative News in the Field of Medical Devices. XX. National Congress of Interdisciplinary Cooperation in the Treatment of Wounds and Skin Defects, Pardubice, May 5, 2022.