Monthly Archives: May 2017

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.