SERIALIZATION FOR MEDICAL DEVICES: WHERE WE'RE AT

The Marchesini Group and SEA Vision - in partnership with Tecnopolo Mario Veronesi in Mirandola – took part in a symposium on a hot topic among experts, namely the new coding regulation of medical devices (MD) introduced by the European MD Regulation 2017/745. The medical devices involved are those used for diagnostic and/or therapeutic purposes, such as syringes, plasters, aerosols and artificial body parts, to mention just a few.
 

What the regulation means

In short, the European Regulation determines the procedures bound to the new unmistakable coding regulations of the MDs registered on the European database“Eudamed”. The most important novelty is bound to the definition of new roles and obligations for importers and distributors, who in the past were exempt from such responsibilities, but which only manufacturers and proxies had. Over the next few years, all these operators will receive explicit mention and juridical acknowledgement of the obligations associated to their roles.
 

Objectives

The objectives of Regulation 2017/745 are the following:

• to ensure greater traceability of the MDs and greater safeguard of public health and patient and user safety;
• to better monitor the MDs by Authorities and to have stricter after-sales checks;
• to improve purchase and waste disposal policies for hospitals and agents.

Transition times

From May 2017 to May 2020, the EC marking of medical devices according to the two current Directives for MDs  (Directive 93/42/EEC and Directive 90/385/EEC) will start to change to the marking method of European Regulation MD 2017/745.

Even if the transition period could take up to May 2024 for devices certified by an appointed organisation according to the Directives in force, new certifications according to those Directives will no longer be issued as of May 27th, 2020.

European Authorities and Appointed Organisations will continue to monitor the EU market to make sure that all the MDs are safe and perform their expected function, be they marked EC according to the current Directives or to the new Regulation.

The regulatory documentation, such as the declaration of conformity, certificates, labels and instructions of use issued according to the current Directives, may be considered valid up to May 2024 and both types of devices can continue to be used and distributed regularly.