Do you want to market a medical device in the EU?

Is my product a medical device? 

 What documentation do I need to produce to affix the CE mark? 

 What should I do after I place my product on the market?

...

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WARNING 

THE REFERENCE LEGISLATION FOR MEDICAL DEVICES IS IN TRANSITION TO THE NEW EUROPEAN REGULATION (MDR), THE FOLLOWING IS RELATED TO EC DIRECTIVE 93/42 (MDD) AND IS ONLY PARTIALLY APPLICABLE TO MDR


The placing on the market of a product falling under the definition of a medical device may only take place following the CE marking, with certain exceptions.  

The manufacturer of the medical device assumes responsibility for legislative compliance, and must therefore demonstrate that he meets the essential requirements of safety and efficacy , or "devices must be designed and manufactured in such a way that their use does not compromise the clinical condition and safety of patients, nor the safety and health of users and possibly third parties, when used under the conditions and for the purposes intended, it being understood that any risks must be of an acceptable level, taking into account the benefit to the patient, and compatible with a high level of protection of health and safety. 

Eumed supports you in choosing the most convenient path and in the creation of the technical product file, that is all the documentation that allows you to demonstrate the fulfillment of the essential requirements and whose drafting requires qualified skills.  

The path to CE marking depends mainly on the risk class of the device. In order to be able to classify the medical device, the manufacturer must comply with the rules contained in Annex IX of MDD. The higher the class of risk, the greater the safety guarantees that the manufacturer must provide for the production of the device.  

Class I devices: in this case the manufacturer declares under his responsibility the conformity of the medical device with the essential requirements obbligatory on the basis of Annex VII of Legislative Decree 46/97, issuing a document with which he guarantees that his products meet the provisions of Directive 93/42. The EC declaration of conformity is the simplest procedure and, as a declaration of assumption of responsibility, does not require the intervention of a Notified Body. 

For products placed on the market in sterile packaging and for devices with a measurement function, even if they belong to class I, the manufacturer must follow one of the procedures provided for in Annexes IV or V or VI, in addition to the provisions of Annex VII. The procedures provided for in Annexes IV, V and VI must be submitted for examination to a Notified Body, whose intervention will be limited: 

  • in the case of sterile products, only those aspects of manufacture which concern the achievement and maintenance of a sterile state; 
  • in the case of devices with a measuring function, only those aspects of manufacture which concern the conformity of the products with the metrological requirements. 

In the case of medical devices of a higher class, the intervention of a Notified Body, that has the task of approving the production facilities and/or the product itself, is necessary for verifying that the manufacturer has carried out all the assessment operations and with further guarantees and stricter controls can proceed to issue the EC certificate of conformity.  

Class IIa devices: the manufacturer has two different procedures to choose from:  

  • Annex II (full quality assurance system) with the exception of point 4. 
  • Annex VII (technical file with EC declaration of conformity) + Annex IV (EC verification) or V (production quality assurance) or VI (product quality assurance). 

Class IIb devices: again, the manufacturer may choose between two different applicable procedures:  

  • Annex II (full quality assurance system) with the exception of point 4. 
  • Annex III (EC type-examination)+ Annex IV (EC verification) or V (production quality assurance) or VI (product quality assurance). 

Class III devices: the manufacturer may choose between the following different procedures: 

  • Annex II (complete quality assurance system) including point 4 (product design review), in fact in this case the Notified Body also has the task of assessing and strictly controlling the design aspect of the product. 
  • Annex III (EC type-examination)+ Annex IV (EC verification) or V (production quality assurance). 

If there are more than one medical device in a single packaging, it falls within the definition of Systems and Kits for which the directive specifies:  

all devices already individually CE marked, in non-sterile packaging, which do not require a new marking. The assembler of these products must draw up and send to the Ministry of Health a declaration in which he certifies that the mutual compatibility of the individual devices assembled according to the manufacturers' instructions has been verified, that he has packed the kit and provided users with the relevant information containing the instructions of each manufacturer and that the entire assembly process is subject to appropriate internal verification and control methods; 

the devices are all individually CE marked, in packaging sterilised by the assembler. In this case, the assembler must follow one of the procedures described in Annexes IV or V or VI, in addition to the requirements of the previous point. The application of this procedure and the intervention of the Notified Body are limited to the sterilization process; devices that are not CE marked or not all individually CE marked. In this case, all the assembled devices become a single medical device and are therefore subject to the normal CE marking procedure. 

In order to affix the CE marking in the case of active implantable devices (with the exception of custom-made devices), on the basis of D. L.vo 507/92 and subsequent amendments, the manufacturer may choose one of the following procedures:  

  • procedure relating to the EC declaration of conformity (Annex II: complete quality assurance system) 
  • procedure for EC type-examination (Annex III) in conjunction with: 
  • procedure relating to EC verification (Annex IV) 
  • procedure relating to the EC declaration of conformity to type (Annex V: production quality assurance) 
Active medical devices (devices that require some form of energy to function, other than that generated directly by the human body or gravity, and that act by converting that energy) intended to be implanted wholly or partially, by surgical or medical intervention, in the human body. They shall be regulated separately from other medical devices.
On the other hand, the manufacturer of tailor-made active implantable devices must draw up a declaration in accordance with the indications set out in Annex VI. In order to affix the CE marking in the case of active implantable medical devices, the essential requirements to be complied with are similar to those described for class III devices, but with specific reference to Directive 90/385/EEC and in Italy by Legislative Decree no. 507 of 14 December 1992, as later supplemented and amended by Directive 2007/47CE and Legislative Decree no. 37 of 25 January 2010.

Eumed, on the basis of twenty years of experience, can support you in choosing the path that best suits your needs, even in the difficult transition that will affect the entry into force of the new EU Regulation.