What is the difference between a Medical Device and Personal Protective Equipment?
In the past months, we have heard a lot about PPE (Personal Protective Equipment), and DM (Medical Device). These two devices differ in their regulations and their purpose of use. Let's see what the main differences are.
A Medical Device (MD) is, widely, an instrument, an apparatus, an equipment, a software, etc. intended by the manufacturer to be used by humans to diagnose, prevent, control, treat or alleviate a disease, injury or handicap, or to study, replace or modify the anatomy or a physiological1 process.
It must therefore be able to protect the person whom it is used on (this may be the user himself, if he uses the MD on/for himself). In order to ensure compliance with specific technical standards, CE marking is mandatory on DMs. It is important to note that each DM has its own set of instructions, which indicate for which purpose it is intended.
The European directive that governs medical devices is Directive 93/42/EEC (translated in Italy by Legislative Decree 46/92), which will soon be replaced by the European Regulation 2017/745.
In Europe, medical devices are classified according to their level of dangerousness, ranking from the lowest l (Class I) to the highest level (Class III). There is also the possibility to have a sterility option and/or a measurement function for class I (which will then be noted as Is, Im or Ism):
- Class I – e.g.: compresses, surgical masks, wheelchairs, restraint bands, ... ;
- Class IIa – e.g.: contact lenses, syringes and needles, skin staples, dental crowns hearing aids, long-term tissue or cell preservation devices, ultrasound scanners, ... ;
- Class IIb – e.g. : haemodialysis machines, infusion pumps, condoms, internal sutures, ... ;
- Class III – e.g.: breast implants, active coronary stents, pacemakers, hip replacements, …
Personal Protective Equipment
The primary function of PPE (Personal Protective Equipment) is to protect the user against potential health and/or safety risks. They are CE marked which guarantees the compliance with the specific technical standards for protection.
The European Regulation 2016/425 regulates and defines the requirements for this personal protective equipment (PPE) (the only difference in Italy is the legislative decree 17/2019)2.
Among the PPE, we find the so-called "FFP" respiratory protection masks (FFP1, FFP2, FFP3), as well as protective glasses, protective visors, certain types of gloves, certain types of gowns or protective suits, ...
In Europe, personal protective equipment is classified according to the level of danger/risk incurred by the user, ranging from a minor risk (category I) to a serious or even fatal risk (category III).
- Category I "minor risks" – e.g.: sunglasses, gardening gloves, aprons, etc;
- Category II "intermediate risks" – e.g.: visors and goggles, safety shoes, cut-resistant gloves, etc;
- Category III "serious or fatal risks" – e.g.: respiratory protective equipment (including FFP), certain gloves and or clothing (gowns, overalls, etc.) for protection against dangerous materials, chemicals or biological agents, harnesses, ropes and fall arrest carabiners, etc.
You will probably notice that some products meet both PPE and DM criteria. In order to determine whether a product is a DM or a PPE, it is necessary to observe the directive/regulation for which the product meets best, through its technical design and its purpose of use.
Shortly, if the purpose of the product is to protect the user, and that it follows the requirements of EU Regulation 2016/425, it will therefore be considered as a PPE. On the other hand, if the product's focus is on safety and improving the patient’s health, and that it follows the requirements set out in Directive 93/42/EEC (or EU Regulation 2017/745), it will be determined as a DM3.
1 Source : AFMPS https://www.afmps.be/fr/public_information/dispositifs_medicaux/qu_est-ce_qu_un_dispositif_medical
2 Source : SPF Economie https://economie.fgov.be/fr/themes/qualite-securite/securite-des-produits-et/reglementations-specifiques/equipements-de-protection/securite-des-equipements-de
3 An exception is made for a particular category of DM: In-Vitro Diagnostic Medical Devices (IVDDs), which follow the requirements of Directive 98/79/EC (or EU Regulation 2017/746).