The new Sanitary Products Regulation

Life Sciences - New Regulation

Our Life Sciences consultant, expert in Quality Assurance, María, talks about the new Sanitary Products Regulation:

The United States Institute of Medicine defines medicine, devices and medical and surgical procedures used in medical care as “health technology”. Health technology has revolutionized the medical sector, due to the medial product’s innovation, more and more sophisticated.. This has considerably increased the hope and the quality of life. However, the existing Guidelines have become obsolete, which is why it has been considered necessary to establish a new Regulation (EU / 2017/745) that constitutes the regulatory framework for this new market. Patient’s safety is the main goal. The Regulation entered into force in May 2017 and will be applied next May, 2020.

What are the key points incorporated in Regulation EU / 2017/745?

The Regulation upholds, in general, requirements imposed by the Directives it replaces (93/42 / EEC and 90/385 / EEC). In addition, it introduces other key points, referred to product safety throughout its life cycle, as well as the need of clinical data.

On the other hand, the Regulation increases its scope of application, including in its capacity, among others, products for cleaning Sanitary Products, active implants and accessories, nanomaterials and computer programs. More stringent provisions are introduced regarding Notified Bodies, to the economic agents involved in the chain (responsible for the registration of Unique Device Identification, UDIs, among other things) and to the labeling of products to improve traceability.

Regarding the classification of Sanitary Products, the division made in the previous Directive is maintained, including the active implants and their accessories in Class III (previous Directive 90/385 / CEE) and the single use products susceptible to be reprocessed in Class I, with the need for intervention by a Notified Body. Four new standards are included.

It is important to point out the classification of computer programs destined to provide information used in making decisions for therapeutic or diagnostic purposes, which will have their own classification rule.

If my sanitary products are certified with Directives 93/42 / EEC and 90/385 / EEC, is it necessary at the time of application of the new Regulation EU / 2017/745, to request a new certification?

Starting from May 2020, certificates will only be issued in accordance with the new Sanitary Products Regulation. However, a validity period has been defined, in which the products certified by the Directives will be on the market until May 2024, as long as their certificates are valid.

During this period, health products will coexist in the market, whose certificate has been issued in accordance with the previous Directive within health products whose certificate has been issued in accordance with the new Regulation EU / 2017/745. Both certificates will have equal conditions before the law according to the European Commission.

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