MDD (Medical Device)
Ente Certificazione Macchine is Notified Body authorized by the European Commission to deliver CE Certificates in accordance with the Directive 93/42/EEC (MDD).
[See ECM on Nando Information System here]
The CE marking is the mandatory certification mark that any medical device must obtain to be marketed in EU, which declares that the product is in compliance with the applicable European Directives. Medical Device Directive 93/42/EEC (MDD) lists the Essential Requirements on safety, efficacy and quality performances that a medical device must meet in order to be CE marked and sold in EU market.
Applicable standards depend on the classification and intended use of the device.
See reference the classification rules in Annex IX of the MDD to determine your device class:
- Class I devices (that could be also "sterile" or "measuring")
- Class IIa/b devices,
- Class III devices.
Class I devices that are not sterile or with measuring function do not require the involvement of a Notified Body, they can be self-certified by the manufacturer. Class I-s, I-m, IIa, IIb, and Class III devices require the Notified Body approval.
ECM is Notified Body for I-s, I-m, IIa, IIb.
Comply with MDD Requirements involves a set of required activities for the manufacturer to demonstrate the conformity of its device.
ECM Medical Device Division is a team of experts experienced in testing, regulatory assessment and quality assurance, able to carry out the whole CE Certification Process.
To medical device market, we provide:
- CE Certification
- Quality Management System ISO 13485 Certification
- Testing Services as Accredited Testing Laboratory ISO 17025
- NCB and CBTL within the IECEE CB Scheme
- Transfer CE and ISO 13485 certification to ECM.
In regard to the entry into force of the new Regulation on medical devices MDR 2017/745 applicable from May 2020, we are pleased to announce that ECM is planning to be a MDR Notified Body. Last December, our technical staff submitted to the competent authorities the MDR application in accordance to the European Medical Device Regulation 2017/745. We will keep you posted on it.