The new Medical Device Regulation 2017/745 introduces important news for medical device manufacturers. Article 120 ‘Transitional Provisions’, in point 3, states:

“[…] the requirements of this Regulation (MDR) relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.”

This means that manufacturers holding an EC certificate, even if issued in accordance with Directive 93/42/EEC, will be required during annual surveillance to comply with certain requirements on Post-Marketing activities in accordance with the new Regulation (EU) 2017/745.

Elements that manufacturers will have to meet include:

• Post Market Surveillance:
  • Vigilance
  • Complaints management
  • Trends reporting
  • Periodic Safety Update Report (PSUR)
• Post-Marketing Clinical Follow-up

• CER updated every 1 or 2 years, depending on the risk class:
  • State of the Art
  • Literature pivotal data
  • Vigilance data about competitor/equivalence devices.

Even if surveillance is carried out for an EC certificate issued according to Directive 93/42/EEC, the above-mentioned points must be updated in accordance with the new MDR. Otherwise a non-conformity will be detected during the surveillance, which may lead in some cases to the suspension of the certificate.

For more information, please contact our Sales Manager Antonio Balassone at antonio@entecerma.it | mob. (+39) 393 2471040