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FREQUENTLY ASKED QUESTIONS

  

IS MY PRODUCT A MEDICAL DEVICE?

According to the regulation (UE) 2017/745, ‘medical device’ (MD) means "any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:    

   ·      diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

·        investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

·        providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

 

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

 

The following products shall also be deemed to be MD:

·        devices for the control or support of conception;

·        products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point."

 

To illustrate the complexity of this definition, here some examples:

 

    Is the baby scale a medical device?

 

 « If the measurements made by the baby scale are not intended, in light of the information on the instruction leaflet and on the packaging, to be made for medical purposes within the meaning of Articles L.5211-1 and R .5211-1 of the Public Health Code, the baby scale is not a medical device ".

(According to the FAQ "List of regulatory positions and qualifications of MD and DMDIV" of the ANSM)

 

    Are frames used with corrective lenses a DM?

 

« Frames intended to be used with corrective lenses constitute an accessory of these corrective lenses because they allow their use. In light of the Article R.5211-9 of the Public Health Code, Medical device’s accessories have to be treated as a medical device in its own right. To this end, frames are medical devices and have to be CE marking in light of the medical devices directive 93/42/EEC regarding medical devices.

(According to the FAQ "List of regulatory positions and qualifications of MD and DMDIV" of the ANSM).

  

How to launch a medical device on the market in europe ?
 

Any medical device must have the "CE mark" to be launched on the market in Europe.

It is important to bring the medical device into compliance with the applicable regulations. At present, it is necessary to comply with the directives 93/42/EEC and 90/385/EEC. The 2017/745 regulation will replace these European directives soon. (see last question)

 
How To obtain CE MARK ?
·    Device class identification
·    Determination of the applicable essential requirements defined by the manufacturer
·    Design of the technical file of the product
·    Choice of a Notified Body to assess compliance during an audit (except class 1 MD: self-certification)
 

 

Annex II : Complete quality assurance system (according to ISO 13485)
Annex III : CE type inspection (design phase analysis)
Annex IV : CE verification (production phase)
Annex V : Quality assurance of production
Annex VI : Quality assurance of products
Annex VII : CE declaration of conformity

 ·    Obtaining the CE mark (the product can circulate on the European markets)

 


<p style=What is the MD CLASSIFICATION?

The classification of a Medical Device permits to define the potential risk for any person involved in the use of this device. This classification is divided in 4 categories from less critical to the most critical: I, IIa, IIb and III. Class I include sterile products (classe IS), devices with a measuring function (IM) and products sterile with a measuring function (class ISM).

 

How DO I determine my medical device class?

 

According to annex VIII of the regulation (EU) 2017/745 - chapter II, it is possible to determine the classification rules and the way they are applied. We can only advise you to look at the comparative table between the new regulation and the medical device directive 93/42/CEE proposed by Guillaume Promé, on his website Qualitiso. He gives also a formulary which is helpful to determine the class of your medical device.

 

  

is An accessory classified as the associated md?

 

According to annex VIII of the article 3.2 (chapter II), rules of classification:
“If the device in question is intended to be used in combination with another device, the classification rules apply separately to each device. The accessories of a MD and the accessories from the list of devices in annex XVI are classified, regardless of the devices with which they are used.” 

 

 

I have a class I MD, DO I have to do a clinical eVALUATION?

 

Yes. In Which cases?

  • Upon receipt of information from the PMS, questioning the current clinical evaluation. (according to Meddev 2.7.1-rev.4-1)
  • Each year; for implantable and class III MD. (according to regulation (EU) 2017/745)
  • Every  2 to 5 years, if MD does not involve significant risks and these risks are well established. (according to Meddev 2.7.1-rev.4-1)

 A justification of delay must be present in the clinical evaluation report.

 
 
 

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How to choose my Notified body?

 

The choice of a Notified Body is an important factor in obtaining CE marking.

NEOMED services recommends that you select your Notified Body from the team-NB members.

 
 

HOW TO DEMONSTRATE THE TECHNICAL EQUIVALENCE OF a md ON THE MARKET?

 

The proof of equivalence is specifically broached in Meddev 2.7 / 1 rev4: "Clinical evaluation: a guide for manufacturers and reporting bodies under directives 93/42/EEC and 90/385/EEC" and in the regulation (EU) 2017/745. These regulations indicate that the equivalence must be carried out according to 3 characteristics: clinical, technical, biological. They list the requirements that can be taken into consideration. Equivalence does not mean that the devices must be strictly identical. Indeed, two devices can be considered as similar when the differences found have no impact on performance and security. These differences must be clearly identified, exposed and evaluated by the manufacturer. When it is possible, the equivalent devices and the device under study can be technically tested. The results are compared in order to argue the equivalence. This comparison strategy can also be applied for biological equivalence to compare toxicity or histological responses, for example. It is important to note that the only clinical data considered relevant are data obtained from CE marked device, used according to its intended use. Exceptions are possible: when the equivalent devices are not CE marked, the regulatory status must be indicated and a justification for the use of its data must be included in the clinical evaluation report. The justification for the use of data should explain whether the clinical data can be applied to the European population.

 

 
 

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