MDR Notice for Class I Manufacturers

The Medical Device Regulation (EU) 2017/745 (MDR), published in May 2017 with a transitional period expected to end on May 26th 2020 – From that date, the Regulation will apply in full.

There is no provision for “grandfathering” within the Regulation. Meaning, all devices will need to comply with the MDR and shall be subject to the appropriate conformity assessment (re-certification) procedure under the MDR.

Devices which a conformity assessment procedure under Directive 93/42/EC did not require them to obtain a notified body certificate – will need to comply with the Regulation as of May 26th 2020!

This will include the following devices:

1 Any Class I device:

–          Without a measuring function and/or supplied not sterile

2 Reusable surgical instruments:

–          Such devices will require an audit by a notified body relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing as well as the related instructions for use.

3 Software:

–          Will be classified in accordance with rule 11 (Annex VIII) under the MDR, which may convert many software to a higher classification than Class I.

4 Any other device:

–          Which the MDR classification rules convert to a higher class.

 

It is therefore critical to understand the provisions of the Regulation and follow the implementing acts which will be soon published (50 are expected).

Significant changes include:

Devices & Technical Documentation

  • Risk classification
  • Safety & performance
  • Technical documentation
  • New labelling requirements
  • Post market surveillance (PMS)
  • Quality management system (QMS)
  • Unique Device Identification system
  • Clinical evaluation Report (CER): equivalence extremely difficult
  • Custom made devices

 

Economic Operators & Registrations

  • New designation of notified bodies
  • NEW Responsibilities for importers, distributors and authorised representatives
  • NEW Responsibilities between OEM & OBL
  • Person Responsible for Regulatory Compliance (PRRC
    • For Manufacturer
    • For Authorized Representatives
  • European database for medical devices (EUDAMED)
    • Registration of Economic operators
    • Registration of Devices & Activities
  • Implants cards and info provided to patients
  • Liability insurance requirements
    • For Manufacturer
    • For Authorized Representatives

 

In addition to the above, it is important to remember the unique role and additional responsibilities Authorized Representatives will undertake under the New Regulation – to name a few:

  • Authorized Representatives will need to accept the designation by signing a specific legal Mandate with the manufacturer.
  • Authorised Representatives will be required to verify that the technical documentation has been drawn up, appropriate conformity assessment procedure has been performed and more.
  • Authorised Representatives will be required to have at least 1 person meeting the qualifications of Person Responsible for Regulatory Compliance – same as the manufacturer.
  • Authorised Representatives will be liable for defective devices – together with the manufacturer.
  • Authorised Representatives will be required to ensure the manufacturer abides with its obligations and have appropriate liability coverage. In case the manufacturer does not fulfil its obligations, Authorized Representatives will be required to terminate the EAR mandate.
  • And more…

 

Time is quickly running short, there is a little over a year before the Regulation enters into force. The changes which need to be implemented are significant requiring urgent action – manufacturers should understand the new regulation requirements, train their staff, brief their top management, perform a gap analysis, obtain the appropriate budget and implement an action plan to meet the MDR deadlines.

As a professional Authorized Representative and EU consultant with over 30 years of expertise on medical device regulations, Obelis aims at supporting manufacturers during this process.

We can provide support towards:

  • QMS – we will create and help you update existing procedures (e.g.: risk management, clinical evaluation, PMS, vigilance…).
  • MDR Training – we will train you on the MDR in general or focus on any particular provision
  • Gap Assessment – we will support you on creating your MDR Gap assessment & action plan
  • Authorized Representative – we will ensure your conformity allowing us to accept the designation mandate under the MDR.
  • Technical Documentation – we will review your Technical File, provide guidance on corrective actions and fully support you to transform your technical file to be MDR compliant.
  • Clinical Evaluation Report (CER) – we will help you update your Clinical Data, support you on clinical literature research and more.

 

If you are a Class I manufacturer and you wish to avoid market disruption and allow a smooth transition from the Medical Device Directives to the Regulation, contact us today to receive a quotation on how we can support your MDR compliance.

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