EU GMP Annex 1
The Medical Device Regulation includes a number of considerations for the use of medicinal products and devices together. However, there is one article, 117, which impacts medicinal products which have an integrated delivery component (such as a pre-filled syringe, patches for transdermal drug delivery and pre-filled inhalers). This delivery component is not classified as a medical device, but must conform with a number of relevant General Safety and Performance Requirements (GSPRs).
The article 117 is an amendment to Directive 2001/83/EC – medicinal products for human use – Annex 1, section 3.2 point 12
- Currently it states:
Where applicable and if needed, a CE marking which is required by Community legislation on medical devices shall be provided.
- It has been replaced with the following:
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.
This states that the medicine Marketing Authorisation dossier must contain the results of the conformity assessment of the device component. If the device component is also used as a standalone device, it would have a CE certificate (or just a Declaration of Conformity if it is a class I device and no Notified Body input is needed). If the device component is not CE marked, a Notified Body Opinion (NBO) is required (if an approval would be needed were it a standalone medical device i.e. for class IIa devices). The MDR General Safety and Performance Requirements (GSPRs) should be addressed where applicable and should be included in the submission to the Notified Body.
The purpose behind this new requirement for a Notified Body Opinion is to ensure that the appropriate stakeholders are involved when approving products for use on the European market.
The European Association of Medical Devices – Notified Bodies (Team-NB) has prepared a position paper (https://www.team-nb.org/wp-content/uploads/2020/04/Team-NB_Position-Paper_on-Documentation-Requirements-Article117-V1.pdf) which contains their proposal regarding the documentation requirements for a submission for a Notified Body Opinion.
It is important to note that this will not be applied retrospectively and will only impact any new medicinal product authorisation applications planned for after 25th May 2021 (or if any significant changes are being made). The Notified Body Opinion review could take 2-3 months plus clock stops for questions, so it is important to start reviewing your product portfolios as soon as possible to ascertain which products may be impacted by article 117 in order to avoid future delays.
The team at Pharmalex are experienced with submissions for Notified Body Opinions under article 117 and are ready to support you to ensure a seamless transition and remove any risk of future non-compliance. Please contact us at contact@pharmalex.com for assistance.
Related posts
