medical devices – from mdd to mdr
Background
Medical devices are used to diagnose, prevent, monitor, treat or alleviate a disease by means of a physiological way of action. Medical apps which may be used to diagnose or help in the treatment of a patient can sometimes be considered as medical device as well. Medical devices in Europe must comply with Regulation 2017/745 (MDR) or the European Directive Directive 93/42/EC (MDD). The certification procedure of a medical device is dependent on the classification of the involved product and usually (except for class I medical devices) a Notified Body approves the application. All medical devices can be recognized by the CE symbol on the packaging material.
Regulatory documentation and services for medical devices
We advise on the classification of a medical device; the classification may be changing due to new classification rules in the MDR. We also advise on certification and notification procedures.
YES Pharma Consultancy B.V. has compiled various parts of technical files for medical devices. For example risk analysis plans/reports, management reviews, technical documents, biological safety evaluation reports (BSER), clinical evaluation reports (CER), post-market clinical follow-up plans/reports (PMCF), and post-market surveillance reports (PMS) have been written meeting the requirements of Dir. 93/42/EC and Reg. 2017/745.
Is your CE Technical File ready for the MDR?
The new Medical Device Regulation 2017/745 (MDR) will apply to medical devices in May 2021. Most legal manufacturers have identified the GAPs in their CE Technical Files between the MDD (Medical Device Directive) and the MDR. Most of you have meanwhile performed additional tests and studies in order to close the identified GAPs.
Post-Market Clinical Follow-Up (PMCF) studies are the most commonly identified GAP under the new MDR and usually the Clinical Evaluation Report (CER) needs attention. In addition, biocompatibility tests are also a commonly identified GAP.
During the last months a lot of helpful guidance documentation has been published. For example, ISO 10993-18: 2020 facilitates the biological evaluation of medical devices according to the MDR requirements. Together with i.e. , the slightly older, standard ISO 10993-1: 2018 you will be able to prepare a proper Biological Safety Evaluation Report (BSER) covering the General Safety and Performance Requirements (GSPRs no. 10) of the MDR concerning the chemical, physical, and biological properties of a medical device.
MEDDEV 2.7/1 rev, 4 provides guidance to the clinical evaluation of medical devices anticipating on the MDR already since June 2016. In addition, the recently (April 2020) published MDCG 2020-5 guideline on Equivalence may provide a more accurate interpretation of Bioequivalence as described in the MDR. Together with the MDCG 2020-13 guideline describing the demands for a Clinical Evaluation Assessment Report and the MDCG 2020-8 guideline describing the demands for a Post-Market Clinical Follow-Up Report it is possible to cover the clinical demands of the MDR properly.
Please contact us if you need assistance during the transition to the MDR. We can compile various parts of your CE MDR proof Technical File. Moreover, we can assist in choosing your notified body and the certification procedures and audits.