ECM Medical Devices Division reaches an important milestone in the compliance of systems and procedure packs with the first certificate issued under Article 22 of the MDR.

We are proud to announce that ECM Notified Body 1282 has recently issued its first certificate under Article 22 of Regulation MDR 2017/745, related to systems and procedure packs. This achievement marks a significant step forward in our commitment to ensuring the compliance of medical devices according to the highest safety and quality standards.

MDR ARTICLE 22 – SYSTEMS AND PROCEDURE PACKS

Article 22 of the MDR Regulation establishes the specific requirements and procedures for combining CE-marked medical devices with other devices or products, in a manner that is compatible with their intended purpose and within the limits of use specified by manufacturers, to place them on the market as a system or procedure pack. The goal is to ensure that these devices, once assembled as system or procedure pack, maintain mutual compatibility and safety in use. This includes, among other aspects, the verification of sterilization according to the manufacturer’s instructions.

THE ECM’S ROLE IN ASSESSING SAFETY AND COMPLIANCE

As Notified Body No. 1282, we worked to verify that system or procedure pack met the requirements set out in the MDR regulation. Our team ensured that sterilization was carried out correctly in compliance with the relevant standards and issued the EU Certificate under Regulation 2017/745.

The issuance of this first certificate under Article 22 is another step in our ongoing work in MDR certification, where we continue to issue certificates. Our commitment is to ensure that every device certified by ECM meets regulatory requirements, providing safety and reliability to end users. With our expertise and competence, we are the ideal partner for manufacturers looking to start the conformity assessment process in compliance with the new EU regulations.

If you would like more information on the devices we can certify, take a look here.

You can contact us anytime to learn more about our MDR certification activities! Send an email to our Sales Department: Diego Stevanella diego.s@entecerma.it – Marzia Pellegrini marzia.p@entecerma.it

Are you interested in starting the certification process but unsure where to begin? Check out our Structured Dialogue service and contact us for more information!