Medical Devices Directive: news and updates from European Notified Body round table
In the last
weeks, it’s been held in Brussels the 56°
coordination meeting of European
Notified Bodies for Medical Devices Directive 1993/42/CE. For ECM,
already involved as Notified Body in many European meeting for the other
directives of our expertise, it has been the first time as Notified Body for Medical Devices Directive,
participating with our Technical Manager Eng. Vanessa Biavati.
faced topics, the most relevant has been the discussion in matter of the new Regulation for Medical Devices (MDR –
Medical Device Regulation), whose emission is expected in the next months.
When the new Directive will be effective, it will replace the actual 93/42/CE,
therefore both manufacturers and Notified Bodies have to face a series of very
going to happen to certificates issued in accordance with the actual directive?
What will change and how long will the transition time be, to let manufacturers
adapt to new requirements? How the Medical Devices classification will change?
only few of many questions put on the table since the validation of the new
regulation, which has to be faced in the next future. In order to answer to manufacturer’s
questions, during the meeting it has been reserved a specific moment of confrontation with Manufacturer’s
Associations, to illustrate and explain the principal consequences of the
transition times, useful for the adaptation of their devices to the new requirements
and the designation of the delegated Notified Body in charge of audits and
words, we are facing a period of huge
changes, which will impact all the parties involved in the certification
process: if the manufacturer must
adequate their own devices to the new standards imposed by the new Directive,
the Notified Bodies has to form their resources in relation to the new MDR. Abuot
that matter, an important topic has regarded the new NBOG Codes proposal (product identification codes in which each
NB is able to operate). Because of the increase of new technologies, one of the
purpose of the new regulation is to give an answer to the need of extend and
specify the Medical Devices codification, in accordance with their applicative
field and intended use.
and fundamental duty of Notified bodies, the discussion has expected an
experiences exchange in matter of unannounces
inspections, an important tool available for manufacturer and designated
Notified bodies to attest an increased security and assuring the quality of the
product on the market.
body for this directive, Ente
Certificazione Macchine is constantly updated about the development and
news of the new MDR, and it’s preparing to face the imminent changes and giving
manufacturers an answer for those needs dictated by the regulation transition
expected in the near future.