EMA – recently published guidance:
The European Medical Agency (EMA) has recently published guidance documentation to support organisations prepare for the obligations arising from the new EU regulations on medical devices and in-vitro diagnostics. The medical devices regulation (Regulation (EU) 2017/745) and the in-vitro diagnostics regulation (Regulation (EU) 2017/746) have replaced the three existing directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices. The new regulations came into effect on the 25th May 2017, however, a transition period has been given to allow manufacturers, notified bodies and authorities to adapt to the changes. Therefore, the new regulations will come into full effect on 26 May 2020 for medical devices (Regulation (EU) 2017/745) and 26 May 2022 for in-vitro diagnostics (Regulation (EU) 2017/746).
The Health Products Regulatory Authority (HPRA) have provided a summary of the two new regulations and have highlighted key points of each regulation as follows:
The three key aspects specific to the medical device regulation (MDR) are:
- More detailed requirements for clinical data for medical devices and its assessment: this provides increased clarity on the requirements for clinical data for medical devices, in particular those of the highest risk, and improves the mechanisms for the assessment of clinical data throughout the lifecycle of a medical device.
- More specific product requirements: Places greater emphasis on product requirements and the specifications for high risk medical devices.
- Broader scope: Inclusion of more products which previously have not been regulated as medical devices, such as dermal fillers and colored contact lenses.
The four key points identified in the in-vitro diagnostic (IVD) medical device regulation are:
- Introduction of a classification system: Classification of IVDs into four different classes based on risk from class A (low) to class D (high).
- Changes to conformity assessment procedures: IVDs classed as B, C and D will all require assessment and certification by a notified body for medical devices prior to being placed on the market. Significant changes in the regulatory system, because previously IVDs were self-declared devices rather than being assesses by a notified body.
- Performance evaluation and clinical data requirements: These requirements are defined in greater detail, along with specific requirements in relation to use of clinical data for IVDs and how clinical studies are performed.
- Changes to requirements for in-house manufacturing of IVDs: The new regulation places requirements on “in-house” IVDs and the healthcare institutions which manufacture them and allows the introduction of additional requirements at national level by individual member states.
There are four key objectives that are common across both regulations:
- Improved performance of notified bodies for medical devices: Greater clarity in the requirements that a certification organisation must have in order to become a notified body for medical devices.
- Improved pre-market assessment of high-risk devices: Both regulations provide for additional pre-market scrutiny of the highest risk medical devices by an independent expert panel operating on behalf of the European regulatory system.
- Enhanced provisions for market surveillance: Both regulations further define and develop the requirements for the continued surveillance of medical devices on the market by manufacturers and by regulatory authorities.
- Governance, coordination and cooperation: Both regulations have specific requirements and structures in place, where the national authorities are required to coordinate with each other, in conjunction with the European Commission.
Further details can be found on the HPRA website at the following link: https://www.hpra.ie/homepage/medical-devices/regulatory-information/new-eu-device-regulations
The most recent EMA guidance document (27 February 2019) provides clarification on Article 117 of the medical device regulation (Regulation (EU) 2017/745), which introduces the new requirement for the involvement of the notified body in relation to a medical product with an ‘integral’ medical device’. The Marketing Authorisation (MA) dossier for this category of medical device is expected to include the results of the assessment of conformity for the device.
The guidance provides clarity on a number of questions as follows:
- What is Article 117 and what does it mean for medicinal products? E.g., requirement for a declaration of conformity or the relevant certificate issued by a notified body.
- When is a medicinal product considered to form an ‘integral’ product in combination with the administration device?
- How will the medical devices Regulations and, in particular Article 117, impact new MA applications?
- When is it required to provide the notified body opinion/EU certificate/declaration of conformity with the Marketing Authorization Application (MAA)?
- At what stage does the notified body opinion need to be submitted?
- How does Article 117 of the medical devices Regulation impact currently authorized medicinal products with an integral medical device?
- Is it necessary to provide a (new or updated) EU certificate/declaration of conformity/notified body opinion if there are changes to the device submitted through a variation/extension?
To read the Questions and Answers document in full, please visit the EMA website on the following link: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
PharmaLex can support the compliance of your organisation with the new regulations, including the provision of regulatory support, auditing and outsourcing solutions for medical devices. To discuss the range of services that we offer, please connect with us on +353 1 846 4742 or email us at contact@pharmalex.com.
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