Medical devices – UNE 13485

As of May 2020, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC will enter into force, ending the adaptation period, and the previous directives will cease to be valid.

RELEVANT INFORMATION: On 24 April, Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745on Medical Devices (MDR) in relation to the dates of application and postponing the entry into application to 26 May 2021 was published in the OJEU.

The extraordinary circumstances arising from the COVID-19 outbreak and the resulting public health crisis, its epidemiological evolution, as well as the additional resources required for Member States, health institutions, economic operators and other persons involved, have led to a one-year postponement of the application of Regulation (EU) 2017/745 on medical devices published in the Official Journal of the European Union (OJEU) of 5 May 2017.

The main objective of this delay is to be able to ensure permanent availability of medical devices on the EU market, including medical devices which are of vital importance in the context of the COVID-19 outbreak. Source: AEMPS (Spanish Agency of Medicines and Health Products)

Until the entry into force of the MDR, all medical devices that are placed on the market must carry the CE marking.The CE marking is a mandatory requirement for the marketing of medical devices in Europe.

In accordance with Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 93/42/EEC concerning medical devices, which sets minimum requirements for manufacturers, importers, manufacturers’ associations and distributors of medical devices to assess and certify products in order to be able to display the CE marking. In addition to this marking, according to the provisions of Royal Decree 1591/2009, of 16 October, the manufacturer must make a declaration of conformity that he will deliver to his customers and keep at the disposal of the Spanish Health Authorities.

In this regard, companies have the option of implementing a specific quality management system for the manufacture of medical devices in accordance with the UNE-EN-ISO 13485 standard and ISO 14971, which covers the Risk Management of Medical Devices.

The Medical Devices Regulations 2017/745, among others, have an impact on the following aspects:

  • New classification rules (type I, IIa, IIb and III of the Medical Devices Regulation). Regulation of the marketing of medical devices and their accessories; new purposes considered to be medical, and other products which, without pursuing medical purposes, are listed in Annex XVI of the Regulation (contact lenses, laser and liposuction equipment, including clinical investigations).
  • For assembled products, so-called system or procedure kits, where these consist of a combination of CE marked products and non-marked products, a declaration shall be required from the person responsible for placing them on the market to verify their compatibility with the manufacturer’s intended purpose; if they are not compatible, the system or procedure kit shall be submitted to the conformity assessment system as a product in its own right and the person responsible shall assume the obligations incumbent on manufacturers.
  • The Commission shall establish, maintain and manage a European Database on Medical Devices (EUDAMED) for the registration of medical devices.
    • It shall allow traceability of products by means of a unique identification system for manufacturers (UDI-DI) and medical devices (UDI-PI), with both codes appearing on the label and packaging of the production unit.
    • Database of manufacturers, importers and authorised representatives (“Economic Agents”) identified by unique registration numbers (Single Registration Numbers).
    • Clinical research database (which will be interoperable with the EU database on clinical trials on medicinal products for human use).
    • Electronic post-market surveillance and monitoring system.
  • Have a compliance officer.
  • Stricter processes for market introduction and for the marketing of products.
  • Clarification of the obligations and responsibilities of economic operators (manufacturers, authorised representatives, importers, distributors): Strengthening of post-market monitoring, surveillance and control of products:
  • Increased transparency and traceability: essential information will be available to professionals, patients and the general public.
  • Identification of the products by means of a unique identification system (UDI) which will facilitate the search of databases and the implementation of the necessary security actions.
  • Improving administrative coordination and cooperation.

Economic agents according to the Medical Devices Regulation:

  • “MANUFACTURER” : a natural or legal person who manufactures, completely refurbishes or has designed a product, and markets it under its name or trademark.
  • “IMPORTER”: any natural or legal person established in the European Union who brings a product from a third country onto the market of the European Union.
  • “DISTRIBUTOR”: any natural or legal person in the supply chain, other than the manufacturer or the importer, who places a product on the market, up to the time of putting the product into circulation.
  • “AUTHORISED REPRESENTATIVE” means any natural or legal person established in the European Union who has received and accepted a written mandate from a manufacturer, situated outside the European Union, to act on behalf of the manufacturer for specific tasks in relation to the manufacturer’s obligations under the MDR (Medical Devices Regulations).
  • “USER”: any health professional or layperson who uses a product.
  • “NOTIFIED BODY”: a conformity assessment body designated in accordance with the MDR.