Regulatory Update

Class I Manufacturers – Protect Your CE Mark

October 2019

This is a service message from Arazy Group Germany – A European Authorized Representative (EU AR) for Class I Medical and IVD Manufacturers. 

MDR /IVDR REQUIREMENTS FOR STANDARD CLASS I MEDICAL AND IVD DEVICES WHO WISH TO BE PLACED IN THE EU MARKET AND CARRY CE MARK AFTER MAY 26TH, 2020.

The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD). The MDR was published in May 2017, marking the start of three years of transition from the MDD and the AIMDD.

The transitional period will end on May 26th, 2020.

Compared to the MDD, requirements for technical documentation are much stricter with MDR, and it is relevant to all Classes Including Class I, which need to comply with:

  • MDR Annex II – Technical Documentation requirements 
  • MDR Annex III – Technical Documentation on Post-Market Surveillance 

Please note that the Quality Management System (QMS) for Class I manufacturers is now required! – previously Class I manufacturers did not need a formal QMS under the MDD 93/42/EEC.

The EU MDR requires that all manufacturers (all classes) will require a QMS, as stated in Article 10, paragraph 9 of the EU MDR. 

In order to continue with the marketing of these devices after May 26, 2020, they must bear the CE mark along with the notified body number, which means that it will require Notified Body certification under the Medical Device Regulation (MDR) by the May, 26 2020 date of application.  If you have any Class I reusable surgical instruments within your product portfolio, we suggest that you will make sure you meet the MDR requirements and recommend that you submit your application for conformity assessment to accredited EU Notified Body immediately.

It is essential to understand that by May 2020, all Class I devices should be classified and fully complied with the new EU medical device regulations.

  1. Assuming it will be class I (Non-sterile, non-surgical reusable and with no measuring function) you will need:
  2. Establish a quality management system (QMS) that complies with the EU MDR/IVDR. ISO 13485 is recommended but not mandatory, and the QMS does not need to be certified by a Notified Body. 
  3. Meet new Post Marketing Surveillance activities. 
  4. Prepare a CE Technical File that complies with the new regulations & demonstrate that the Medical device meets the relevant general safety and performance requirements of Annex I of the medical devices Regulation 2017/745.
  5. If your company is located outside of the EEA, you must appoint an EU Authorized Representative in one of the EU member’s states.
  6. Write a Declaration of Conformity.
  7. European Authorized Representative of manufacturers located outside of the EEA, must register the manufacturer and the products with the local Competent Authority
  8. CE mark your devices (Place the relevant label on the product).

“Class I r (reusable)” – The EU MDR 2017/745) introduces new requirements for Reusable Surgical Instruments. The EU MDR requires that aspects of reuse of Reusable Surgical Instruments are subject to conformity assessment by Notified Bodies.  Have you approached a Notified Body to accreditation your class Ir devices? Are you familiar with the required conformity assessment?

 

LET ARAZY GROUP ASSIST YOU 

Please let us know where you need help. Contact us at info@arazygroup.com, indicating the numbers next to an item that best represents your current status.

  1. Technical File: I already have a Technical File in compliance with the MDR/ IVDR
  2. Technical File: I need help putting together a Technical File in accordance with MDR/IVDR (including gap analysis of our current files).
  3. QMS: I want to implement the very essential MDR QMS
  4. QMS: I want to implement a QMS that will meet ISO13485 requirements + MDR
  5. QMS: I already have a QMS in compliance with the MDR.
  6. QMS: I Already have a QMS in compliance with ISO13485