Since the introduction of EU Medical Device Regulation 2017/745, manufacturers have been rushing to prepare for it taking full effect on 25th May 2020. The best advice is to start getting ready for the transition now to ensure a smooth process with no negative effects. The first step in getting ready for MDR 2017/745 is understanding what it is and what requirements it has for manufacturers of medical devices. With that in mind, we put some information together to help clear the process up!
The first thing many manufacturers will need to understand is that MDR 2017/745, amending Directive 93/42/EEC, widens the scope of what was once understood to be a ‘medical device’ to include “products without an intended medical purpose” (or aesthetic products). The implication of this is that now manufacturers specializing in products like contact lenses, facial dermal fillers, liposuction equipment, lasers for skin resurfacing or tattoo/hair removal, electromagnetic brain stimulation equipment, etc., will now have to comply with the terms of the new regulation. Such devices have been included due to their being considered as having some of the same characteristics or risks to use as medical devices already under the scope of the previous MDR. All manufactures concerned will also need to inform themselves on the new notification and post-market surveillance requirements (see below).
An advisable initial step for any manufacturer starting the compliance process is to review their full portfolio of products, identify any devices that may fall under the scope of MDR 2017/745, and finally conduct a strict assessment of their current levels of compliance.
After assessing which devices need upgraded compliance processes or information, the next step is to compile a Clinical Evaluation Report (CER) to ensure/communicate a product’s compliance with 2017/745. Some of the following other items/information, and their status in relation to compliance, may be required too by a Notified Body:
- Device classification information
- Labelling and packaging
- Post-market surveillance procedures
- Risk management processes
- Technical File
- Lifecycle plan for product
- Identification of applicable standards
Preparing for MDR 2017/745 also involves understanding and taking steps to bring practices into line with new post-market surveillance requirements introduced by the regulation. The aim of the regulation is to make products, and therefore all safety information, more transparent within the European community; as such, 2017/745 has introduced both the EUDAMED database and a requirement for a Unique Device Identification (UDI) to be affixed to each affected medical device’s packaging. The most immediate step to be taken here is the call for an incident reporting, risk management and reporting process for each device, as well as encouraging manufacturers to notify healthcare professionals of potential health risks associated with the product.
Though the regulation, as stated above, leaves some time for manufacturers to bring all products into compliance – including the provision that any product issued with a CE Certificate to date will have that certificate remain valid until the indicated expiry date – it is highly advisable that processes are put in place as soon as possible to ensure a smooth transition.
For more information on Medical Device Regulation 2017/745 and how it may affect your product, for general CE Marking enquiries, or for some advice from our team of European regulatory experts, contact us today!