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trict require­ments for devel­op­ment doc­u­men­ta­tion for the approval of drugs are a matter of course for drug man­u­fac­turers. Until recently, man­u­fac­turers of med­ical devices, in con­trast, were sub­ject to rather vague require­ments under the Med­ical Devices Direc­tive. This changed in May 2017 when the EU Med­ical Device Reg­u­la­tion (MDR) replaced the old direc­tive and reg­u­lated the require­ments for the doc­u­men­ta­tion of med­ical devices in much more detail. The draft of the Euro­pean Med­i­cines Agency (EMA) with its reg­u­la­tion on quality stan­dards for drug device com­bi­na­tions goes one step further.

What is at issue?

Drug device com­bi­na­tions (DDCs) con­sist of a device and a drug to be admin­is­tered with it. A dis­tinc­tion is made between inte­gral and non-inte­gral DDCs. We speak of an inte­gral DDC when a device – a syringe, a pen or an inhaler – is already filled with a drug during pro­duc­tion. A non-inte­gral DDC con­sists of an unfilled device that has been specif­i­cally designed for a par­tic­ular drug and is pack­aged with the drug. For both vari­ants, only the proof of effi­cacy of the drug had to be pro­vided so far. Man­u­fac­turers did not have to submit any devel­op­ment doc­u­men­ta­tion for the approval of the device.

This is now changing: For the first time, the EMA direc­tive demands that med­ical device man­u­fac­turers must specify how a device influ­ences the quality of the entire product. In the future, they will have to submit com­plete and pre­cise devel­op­ment doc­u­men­ta­tion for the device as well, including proof of inte­grated risk management.

Over the next few months, this will create some bustle and the occa­sional out­break of sweat, espe­cially among med­ical device man­u­fac­turers. In con­trast to phar­ma­ceu­tical prod­ucts, where the new require­ments only apply to new approvals, med­ical ­device man­u­fac­turers also have to re-doc­u­ment prod­ucts that have already been approved and reg­ister them anew. It’s a Her­culean task, with the clock ticking on top of every­thing else: The new direc­tive is to take effect in 2021.

Backed by expe­ri­ence through the ­thicket of regulations

Since the begin­ning of the year, Harro Höfliger has also been sup­porting cus­tomers in the devel­op­ment of new devices and med­ical prod­ucts or in the opti­miza­tion of existing ones with its “Device Ser­vices” offering. And although the com­pany is nei­ther a phar­ma­ceu­tical man­u­fac­turer within the meaning of the German Med­i­cines Act (Arzneimittel­gesetz) nor a man­u­fac­turer of med­ical devices within the meaning of MDR, the ser­vice offering also includes preparing and pro­viding detailed devel­op­ment doc­u­men­ta­tion for the device.

The EMA direc­tive demands that med­ical device man­u­fac­turers must specify how a device influ­ences the quality of the entire product.

As a basis serves Harro Höfliger’s com­pli­ance with the Euro­pean ISO 13485 stan­dard and the US Fed­eral Food and Drug Admin­is­tra­tion (FDA) 21 CFR820 guide­line. In recent years, both direc­tives have con­verged to such an extent that they are almost identical.

In addi­tion, Harro Höfliger incor­po­rates the require­ments of the ICHQ9 guide­line into the device doc­u­men­ta­tion and thus covers infor­ma­tion on quality and risk man­age­ment that must be doc­u­mented. The three guide­lines together meet all the require­ments of the new EMA spec­i­fi­ca­tions. Con­se­quently, Harro Höfliger cus­tomers receive detailed and EMA-com­pliant devel­op­ment doc­u­men­ta­tion for their device, which they can use for their product approval.

Tar­geted support

There are already ini­tial inquiries from cus­tomers, who in view of the struc­tured device devel­op­ment doc­u­men­ta­tion of Harro Höfliger also desire sup­port with the doc­u­men­ta­tion for their com­plete product. This shows the degree of uncer­tainty regarding the new EMA Direc­tive. With our expe­ri­ence in the field of machine and device doc­u­men­ta­tion as well as the ALL YOU NEED ser­vice phi­los­ophy, Harro Höfliger can pro­vide exten­sive sup­port in this area.

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Photos and graphics: Adobe Stock/ra2 studio, shutterstock/veronchick_84