Who will issue free sale certificate for notified medical devices?

Listed medical devices

Directive 98/79/EC of the European Parliament and of the Council (3) constitutes the Union’s regulatory framework for in vitro diagnostic medical devices. However, a thorough revision of that Directive is necessary in order to establish a robust, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices that ensures a high level of safety and health protection while supporting innovation.

This Regulation does not aim to harmonize the rules concerning the placing on the market of in vitro diagnostic medical devices after they have been put into service, for example in the context of second-hand sales.

Certain key elements of the existing regulatory approach, such as the supervision of notified bodies, risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance of devices and market surveillance, should be significantly strengthened, while introducing provisions ensuring transparency and traceability with regard to in vitro diagnostic medical devices, in order to better protect health and improve safety.

Aemps medical devices

On the other hand, Law 29/2006, of July 26, 2006, on guarantees and rational use of medicines and medical devices, includes medical devices in its scope of application, establishing various provisions in relation to these products, which are developed in this Royal Decree.

The aforementioned Royal Decree 414/1996, of March 1, 1996, has undergone several amendments during its validity in order to update it in line with the experience acquired during its application, as well as to incorporate the new regulations resulting from Community provisions.

Read more  Can we get police clearance anywhere?

The purpose of the legislation on medical devices is to guarantee their free circulation within the Community territory, offering, in turn, a high level of protection, so that the products in circulation do not present risks to the health or safety of patients, users or third parties and achieve the performance assigned by the manufacturer, when used under the foreseen conditions.

Fabricaps

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

Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory framework for medical devices other than in vitro diagnostic medical devices. However, a thorough revision of those Directives is necessary in order to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of safety and health protection while supporting innovation.

This Regulation does not aim to harmonize the rules relating to the placing on the market of medical devices after they have been put into service, as is the case in the context of second-hand sales.

Some key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, should be significantly strengthened, while introducing provisions ensuring transparency and traceability with regard to medical devices, in order to better protect health and improve safety.

Rd of medical devices

Although there are new business possibilities outside the national market, it is important to keep in mind that the national government limits these operations when we are facing a shortage in the market of these products.

Read more  What are the possible consequences of moving in a tenant without a valid gas safety certificate?

Personal Protective Equipment is regulated in REGULATION (EU) 2016/425 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC defines Personal Protective Equipment:

Recently on April 26, the COMMISSION IMPLEMENTING REGULATION (EU) 2020/402 of 14 March 2020 making the export of certain products subject to the presentation of an export license and requiring administrative export authorizations on those equipment listed in its Annex that are in compliance with the provisions of Regulation (EU) 2016/425 of the European Parliament and of the Council or Council Directive 93/42/EEC, Class I medical devices, entered into force.