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EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

Medical Device Manufacturers: MDR Deadline is May 2021.

The European medical device industry will undergo significant changes as a result of the new medical device regulation MDR EU2017/745 – dated May 26th, 2017.

MDR Compliance is more severe than MDD

As the name suggests, it is now a regulation (no longer a directive) and all medical device companies that sell medical products in Europe must adhere to the new regulation.

Companies that do not follow this regulation will not be allowed to sell their medical products in the European Union after May 26th, 2020. The impact can be severe.

Even worse, the expected EU NB Bottleneck is real. Per the EU: “Another Notified Body Bows Out Ahead of MDR – the Investment is Too High!

Before you start, you should clarify the following with your Notified Body:

  • Will your Notified Body be certified by MDR?
    • Yes: Save your MDR audit date!
    • No: Change your Notified Body as soon as Possible!!

Device Classification:

In a first step you should check if the new MDR rules have any impact on your existing or future products classifications.

We can help you navigate this process with your Notified Body.

Economic Operators:

Depending on your business you may have one or multiple economic operator responsibilities which is imperative to know before you start with a gap analysis. Economic operators are Manufacturers, Importers, Distributors or Authorized Representative. Each of them have different requirements to fulfill per the MDR. 

We can help you get a better understanding of each operator role and what their responsibilities are.

Gap Analysis:

Your journey towards compliance starts with a Gap Analysis.

  1. Identify the Articles and Annexes which apply to your business and products.MDR Gap Analysis
    1. We can help you with this onerous process.
  2. With knowledge of Articles and Annexes that apply – perform a Gap Analysis to evaluate your system compliance.
    1. We can support this process.
  3. Develop an Action Plan.
    1. Corrective actions prioritized by risk.

Implementation:

With your corrective action plan in place, you’ll progress to the implementation phase.

It’s important to make sure you’ve addressed the following items: 

  1. Technical file: The technical file update will be executed according to the MDR requirements.
  2. Risk management according to ISO 14971: Your risk management activities (plan, analysis and report) should be aligned with your PMS and PMCF activities.
  3. UDI System: Each medical device needs a UDI-DI (Unique Device Identification – Device Identifier) and UDI-PI (Unique Device Identification – Production Identifier) and must be submitted and transferred to the UDI database. (per EU Commission)
  4. Post Market Surveillance (PMS): Post market surveillance is defined in Chapter VII of the MDR.
  5. Post Market Clinical Follow-Up (PMCF): Manufacturers should conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.
  6. Clinical Evaluation: According to MEDDEV 2.7.1 Rev 4.
  7. Labeling: Manufacturers shall ensure the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible, clearly comprehensible to the intended user or patient.
  8. EUDAMED registration: Currently the EUDAMED is not online but a first Functional Specification is available. The initial release will be March 2020. Any changes to the release date will be communicated accordingly
  9. Common Specifications: Take care about upcoming specification updates.We keep you informed with our Advantu EU Regulatory Updates, according to ISO 13485:2016, Chapter 5.6 Management Review.
  10. Verification/Improvement: Performing internal audits and a final mock audit to ensure the key requirements have been implemented.

Next Steps:

Do you have an EU MDR Plan in place?
If not, do you have an active project in place to get ready?
  • If not, give us a call.

If Yes – are you on schedule and have all the resources you need?

For those concerned with the In Vitro Diagnostic Regulation (IVDR) here’s our latest blog: “IVDR – What it is & why early compliance matters.”

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