Certification of medical devices

Medical device consultancy

The medical device sector must comply with regulatory requirements and convince potential customers that it manufactures reliable and safe products. A strong commitment to quality can help clients achieve both these objectives and others.

At Emasconsultors, we can assist you with the following medical device consultancy services:

  • Medical device approval. Obtaining the CE marking for medical devices.
  • With the CE marking, the manufacturer/importer indicates to users and competent authorities that the equipment placed on the market complies with applicable legislation.
  • ISO 13485 certification for medical devices. We help you implement the ISO 13485 requirements to achieve certification.
  • Preparation of technical dossiers for medical devices and in vitro diagnostic devices.
  • Implementation of MDSAP (Medical Device Single Audit Programme).
  • ISO 13485 audits that provide added value, internal audits (Part 1), supplier audits (Part 2) or integrated management system audits.

We can also assist you in obtaining the 

  • Manufacturer, importer, steriliser or consolidator licence.
  • Distribution notification to the regional government.
  • Notifications regarding the marketing of medical devices.

What is a medical device?

It sets out the requirements for the certification of medical devices, as well as the CE marking that enables them to be legally placed on the European market.

A medical device refers to any instrument, apparatus, equipment, material or other article, whether used alone or in combination (including software necessary for its proper functioning), intended by the manufacturer to be used in humans for the purposes of:

  • Diagnosis, prevention, monitoring and treatment of a disease.
  • Diagnosis, monitoring, treatment, alleviation or alleviation of an injury or impairment.
  • Investigating, replacing or modifying the anatomy or a physiological process.
  • Regulating conception.

Furthermore, it must not achieve the principal intended action within or on the surface of the human body by pharmacological, immunological or metabolic means.

Procedure for the evaluation of medical devices

Based on the identification and categorisation of the risks that each medical device may pose to the user, its conformity assessment is determined, thereby enabling the device to obtain medical device certification.
 
  • Product classification and initial assessment: the class of the medical device is determined, along with all the steps required for CE certification.
  • Preparation of the technical dossier. This involves analysing the technical documentation for the medical device and preparing the necessary documentation to compile the technical dossier. To compile the technical dossier, testing may be required.
  • Review and drafting of manuals and procedures. Procedures, protocols, instructions and records, in accordance with the guidelines of the ISO 13485 standard.
  • Processing of the CE marking, supported by a Notified Body (where applicable).
  • Audit at the company’s premises. This involves the assessment of the product’s manufacture and the documentation system at the organisation’s premises, based on the Annex to the applicable directive.
  • Issuance of the CE certificate. Based on the results obtained from the document analysis and the audit.
  • Maintenance and surveillance of the certification: periodic checks to ensure continued compliance with the requirements of the directive.
 

Related links

  •  Directive 93/42/EEC – Spanish Agency for Medicines and Health Products (AEMPS).