Hashtags#: To date, LinkedIn identifies 162 followers of #combinationproducts whereas the values for followers of #medicaldevice and #pharmaceuticals are 42 thousand and >1 million respectively. I find the figure for combination product followers disheartening especially when ascribing the low number as a direct proportion of individuals interested in this product category v number of possible LinkedIn regulatory affairs professionals engaged in combination product compliance. (Granted this interpretation is woefully unscientific – just presenting the observation for debate.)
The pharmaceutical and medical device industries are diligently striving to implement procedures, processes, justifications and documented evidence to support and manage compliance against Article 117 of the medical device regulation in time for the 26 May 2021 date of application. Article 117 of the medical device regulation, these two short paragraphs, strikes fear and uncertainty into the working lives of all regulatory professionals responsible for the life-cycle maintenance of any integral drug-device combination product (DDCs) destined for the European market or those markets reliant on CE marking for registration:
“Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council, a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer’s EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.”
“If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.”
The notified body, BSI Netherlands, has recently published notification to the regulatory world that they are the first to issue a Notified Body Opinion in relation to the requisites of Article 117. One adept manufacturer has already successfully manoeuvred through the process and obtained the golden chalice. There may be a glimmer of hope for those struggling regulatory operational teams, to hear the success story at a future virtual event.
The MDR also stipulates requirements for those medical devices containing medicinal substances, when the device has the primary mode of action, via classification rules 14 (medicine is integral and ancillary) and 21 (substance is intended to be introduced into the body).
Be advised that due to (or in spite of) Brexit, the MHRA will continue to regulate DDC products and devices containing medicines, according to the EU MDD as transposed by the UK MDR 2002 (as amended). Of course, compliance is not free:
MHRA Drug-device combination products: fees
|Device which incorporates a known medicinal substance from a source previously used in medicinal products or in medical devices where the MHRA has previously been consulted||£4,136|
|Request by a notified body to the MHRA to supply an additional assessment report||£818|
|Device which incorporates a known medicinal substance from a new source||£9,640|
|Notified body request to the MHRA to supply an additional assessment report||£2,228|
|Device incorporating a new active substance||£42,296|
|Request by a notified body for the MHRA to supply an additional assessment report||£10,501|
As of 01 January 2021, all medical devices placed on the market or put into service in the UK must be registered with MHRA. This obligation for registration also includes medical devices, such as syringes or spoons, that are co-packaged (non-integral) with a medicinal product.
Be reminded that non-UK manufacturers must assign a UK Responsible Person (UKRP) to complete the registration process. The MHRA has allocated a grace period for the notification, based upon classification. This grace period only applies to those medical device products which previously did not need to be registered with the MHRA. If your new device to be placed on the UK market post-Brexit would have required registration with the MHRA prior to 30 December 2020, then the grace period does not apply and immediate registration is necessary.
Pharmaceutical regulatory affairs teams, please reach out to your medical device regulatory colleagues for support and collaboration. Allow them the opportunity to impart the requisite knowledge and expertise to overcome the combination product legislative challenges, for successful goal achievement – ensuring life-enhancing products remain in the marketplace for our patients.