All devices, regardless of the classification, are required by Article 5, 2. to fulfil the general safety and performance requirements of Annex I.
Start with planning the various risk management activities listed in Chapter I. Keep in mind that risk management during development doesn’t finish with a positive benefit-risk report. The final step is the preparation of the post-market surveillance plan (Article 84 and Section 1.1 of Annex III).
Read through Chapter II and make a list of the applicable requirements for your device. Consider how each of those requirements will eventually be shown to have been satisfied during the development. Most companies create a requirements checklist.
Identify any “harmonised” EN and CENELEC standards” (Article 8) which are applicable, and any EU “common specifications" (Article 9) which have to be fulfilled. Lists of these are published in the Official Journal of the EU.
Don't forget that other EU directives and regulations may also apply to the device. For example; environmental (e.g. for batteries) or health & safety (e.g. for hazardous substances) regulations.
Finally, consider also how you are going to satisfy the various “information” requirements (i.e. labelling and instructions) listed in Chapter III. If the device is going to be a high-risk Class III device, you will also need to develop a summary of safety and clinical performance for uploading to the European registration database (See Article 32) and potentially an implant card (See Article 18).
Deliverables for demonstrating compliance:
(1) The Risk Management file,
(2) The General Requirements checklist,
(3) The labelling and instructions for use, including potentially a summary of safety and clinical performance and an implant card.
(4) The Post-Market Surveillance plan.
Guidance
Guidance is also available from the Medical Device Coordination Group and the Scientific Committee on Health, Environmental and Emerging Risks;
- MDCG 2021-8 Annex 6 Checklist of general safety and performance requirements, Standards, common specifications and scientific advice.
- MDCG 2021-11 Guidance on Implant Card – Device types.
- MDCG 2021-5 Rev.1 Guidance on standardisation for medical devices.
- MDCG 2019-16 Rev.1 Guidance on cybersecurity for medical devices.
- MDCG 2019-8 Rev.2 Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices.
- SCHEER guidelines (June 24) Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.
Does benchmark testing to harmonised standards need to take place on EU soil?
Thank you for your question about benchmark testing locations.
There is no such requirement in the EU MDR. However, for clinical evaluations, including usability testing, there is a requirement for the intended users, the clinical environment, the target patient population to be representative of the intended normal conditions of use of the device (Annex XV, 2.4).