Tag Archives: medical device directives

Updated – fifteen things you need to know about the Medical Device Regulation

Update: Since we first published the 15 things, the Medical Device Regulation has moved on apace:

  • The MDR was approved by the European Parliament on 5 April 2017
  • The MDR was published in the Official Journal of the EU on 5 May 2017 and came into force on 25 May 2017

While the detailed MDR text is of interest to people working within regulatory affairs, everyone else probably wants to find out “what does it mean for me?”

So, here are 15 things you need to know about the MDR:

Thing 1.

You will need to consider how your device / technology / combination product is managed throughout it’s life-cycle, as the MDR proposes a broader focus than the pre-approval view taken by the Medical Devices Directive. This means that you will have to follow up on quality, performance and safety of devices after they are placed on the market

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Catching up with the Pharmaceutical regulations, where the role of the Qualified Person has been required for some years, you’ll be required to have a “responsible person” within your organisation, to safeguard regulatory compliance

Thing 3.

Unique Device Identifiers will be introduced, similar to the system in place for the US market

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The role of your Notified Body will evolve from being an industry “helper” to an extension of competent authorities’ market surveillance apparatus. They will have to complete a rigorous application process before re-achieving Notified Body status and will be monitored for both competence and ethical operation

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You will be subject to unannounced audits from your Notified Body at least every 5 years. These audits will cover not just the medical device manufacturer, but also their suppliers and sub-contractors

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You’ll have two Regulations to comply with, instead of 3 Directives (let alone the 28 different pieces of national legislation to enact them in member states) and at least 4 guidances (MEDDEVs)

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A higher bar for clinical data looks likely for lower risk medical devices, equivalence won’t be commonly available as a route to demonstrate clinical safety or performance. For implantable and Class III devices, clinical investigations are likely to be the norm

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You’ll have a specific regulatory body to deal with for expert review of your submissions for higher risk devices, the Medical Device Coordination Group

Thing 9.

Those products you have classified as “accessories” at the moment will become medical devices, if they’re used with cleaning, disinfection or sterilisation medical devices

Thing 10.

Devices like coloured cosmetic contact lenses, without a medical purpose but with characteristics similar to medical devices, will fall within the scope of MDR

Thing 11.

Should you be in the unfortunate position where injured patients or their representatives are seeking compensation for a defective medical device, the technical documentation you produced to demonstrate conformity can be shared by authorities with patients or their representatives

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If you aren’t already, you will be required to use a Quality Management system

Thing 13.

The Essential Requirements have grown, so you’ll probably want to review and update your Essential Requirements checklist

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Medical devices look likely to be labelled as such, similarly to that already required for an In-vitro Diagnostic device. This could lead to a new “MD” symbol being defined

Thing 15.

You have some time to get ready, even though the Regulation is now law in the EU. It is probably a good idea to become familiar with the changes so you’re not playing catch up with your competitors and the regulators.

  • The MDR and IVDR were approved by the European Parliament on 5 April 2017
  • The MDR and IVDR were published in the Official Journal of the EU on 5 May 2017 and came into force on 25 May 2017
  • There’s a transition period of three years for the MDR, so until May 2020.  Compliance with the MDR becomes mandatory.
  • Similarly, for the IVDR, there’s a five year transition period until May 2022.

What next?

Now that you’ve read the 15 things you need to know, you may find it helpful to talk with someone about what you’ll be doing differently for your upcoming projects, existing processes and quality systems.

Give us a call or send an email to start the discussion,

Self-certification, what’s the Medical Device Regulation done with it?

There’s a heart stopping moment in store for manufacturers of low risk, non-invasive medical devices!

The EU Medical Device Directive contained a number of Annexes that mapped out the various routes to demonstrating Conformity with its provisions.  These ranged from the self-certification for Class I, non-measuring, non-sterile devices, through to certification of both your Quality Management System and the medical device by a Notified Body, coupled with regular surveillance visits and re-certification.

Developers and manufacturers have become accustomed to simply checking the Annexes to establish which route to Conformity made sense for their medical device and business.

Everything changes with the Medical Device Regulation?

Then, along came the Medical Device Regulation (MDR).  In case you’re not already aware, the MDR becomes effective on 25 May this year, with a 3 year transition that finishes on 25 May 2020.  Yes, there are some the major changes to the content, and closer alignment of the MDR with similar regulations for pharmaceutical products.

But, when you reach for the MDR Annexes to check Conformity for that device you have in development, you may notice that one Annex is missing!

The Annex formerly known as “Annex VII EC Declaration of Conformity” has gone!

Yep, the route for self-certification of low risk Class I devices by their manufacturers has disappeared.

What the Medical Device Regulation changes mean

We had calls from several clients recently, panicked that their low risk devices would in future need a Notified Body to certify their QMS and Technical File.  In some cases, this could sound the death knell for their device.

Fortunately, our team were ready to calm these troubled waters.  And here’s what we shared with our worried clients:

  • Yes, the previous content of Annex VII has gone from the MDR.  However, the main body of the MDR reveals the following provision in Article 52:

“7.  Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III.”

  • So, the self-certification route to Conformity still exists, for those low risk Class I, non-measuring, non-sterile medical devices.  The requirements for documentation of your Technical File and Post Market Surveillance are detailed in Annexes II and III, rather than being buried elsewhere.

The team went on to outline how the documentation will need to be structured and typical contents that our clients would be required to develop.  Naturally, we will be there to help them through this.

Perhaps you’d like to have a similar conversation with our team?  Get in touch today.

 

The directives are a-changing

A long awaited proposal for revisions to the EU Medical Device Directives was published on 26 September.

The revisions aim to address a range of issues:

      • Existing EU rules have not kept pace with the enormous technological and scientific progress in the past 20 years.
      • EU countries interpret and implement the current rules in different ways.
      • It is not always possible to trace medical devices back to their supplier. New rules on traceability are needed.
      • Patients, healthcare professionals and other interested parties do not have access to essential information on how medical devices have been assessed, and what clinical evidence there is to show they are safe and effective.

The plan is to adopt changes to address these issues in 2014, with implementation between 2015 and 2019,  Expect to see a tightening up on requirements for supporting clinical evidence, increased powers of inspection for assessment bodies (including unannounced inspections).  Medical device risk classification categories are expected to increase to 4, instead of the current 3.

Read the detail of the revision proposals on the European Commission Public Health website here