Does your business manufacture medical devices used to weigh patients, such as baby scales, hospital beds or medicines? If you do, and you want to maintain access to the EU market, then adherence to the NAWI Directive 2014/31/EU and the recently introduced Medical Device Regulation (EU) 2017/745 are crucial.
When the Medical Devices Regulation EU 2017/745 (MDR) replaced the Medical Devices Directive 93/42/EEC (MDD) in May this year, medical device manufacturers turned their focus on ensuring MDR compliance. However, MDR isn’t the only legislation manufacturers must adhere to.
In addition to MDR, a key document in the regulation of medical scales is the Non-Automatic Weighing Instruments Directive 2014/31/EU (or NAWI for short). This vital document defines the legal requirements for weighing scales used in the EU. It applies to all scales used to determine:
- mass for making up medicines on prescription in a pharmacy,
- mass in analyses carried out in medical and pharmaceutical laboratories, and
- mass of patients for the purposes of monitoring, diagnosis, and medical treatment.
Checking compliance to the NAWI directive is simple
Every scale certified under the NAWI directive is placed on the market with an EU-Type Examination Certificate. You can easily check if the metrological markings (CE mark + M + year of putting into use + notified body number involved) are identified on the medical device markings plate. This indicates conformity with the NAWI directive.
Weighing scales for medical use should be serviced annually to ensure continued compliance with the NAWI directive to maintain their class approval and correct performance. Consistent servicing can provide accurate results in medical environments, such as ensuring correct doses of medication administered in correlation to a person’s weight.
Want to learn more?
NMi Certin is here to answer your questions. We provide (Module B) type examination and (Module D) quality assurance certification under the directive 2014/31/EU.
For more information and guidance meeting NAWI Directive requirements today, no matter your location, contact us today.
