EU Medical Device Regulation (MDR) - Summary of Timeline & 9 Pointers

December 18, 2018

 

Both the Council Directive 93/42/EEC (MDD) and Council Directive 90/385/EEC (AIMDD) will transition into the Medical Device Regulations 2017/745.

 Summary Pointers of EU MDR

  1. Stricter pre-market control of high risk devices;

  2. Reinforced designation and oversight of notified bodies;

  3. Inclusion of products w/o medical purpose;

  4. Comprehensive EU database (EUDAMED) & UDI;

  5. Implant Card;

  6. Rules of clinical data and clinical investigations;

  7. Data about the real-life use of devices;

  8. Reprocessing of medical devices; and

  9. Clarification of role and responsibilities of 4 economic operators.

According to Article 120 of the MDR, "Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024."

 

*Important Note: There will be a hard stop sale of MDD self-declared Class I Medical Devices on May 26,2020. MDs can be placed in the EU market under MDD till 2025 but only for exisiting higher risks MDs that have undergone conformity assessment and with no upcoming significant changes.

 

Summary Timeline of EU MDR

Reference taken from TUV SUD, which has also shared on the wave analogy on the changes, as seen below:

 

 

Notified Bodies Designation Status:

 

  • MDD Notified Bodies before 2012:                                                  90

  • MDD Notified Bodies now:                                                               55 (partly with reduced scope)

  • Applied for MDR designation up to now:                                        26

  • Audited so far:                                                                                    12 - 13

  • CAOA report submitted by designating authority to EU:               7

  • Recommended for designation:                                                        0

 

New Notified Bodies list under MDR estimated to be released in Q1 2019. 

 

Another news: For manufacturers that are concerned about the Brexit, the NANDO database has recently included the new Notified Body BSI Group The Netherlands B.V., with the identification number NB 2797. This gives them the authority to carry out conformity assessment according to the directives:

  •  90/385/EEC Active implantable medical devices;

  •  93/42/EEC Medical devices; and 

  •  98/79/EC In vitro diagnostic medical devices.

 

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