Regulatory The spirit and the letter


In spirit, MDR exists to improve regulatory processes and ensure the safety of products all the way from the manufacturers to the end-users, but its advantages and disadvantages are a matter of perspective. Depending on how one looks at it, increased regulatory scrutiny, additional responsibilities and a wider definition of medical devices could be important steps towards ensuring safety or a costly limit on innovation that prevents patients getting the devices they need. One thing everyone can agree on is that the cost of achieving and maintaining regulatory compliance has shot up under MDR. There’s also less room for manufacturers to have their own perspective when it comes to the specific requirements of MDR. Although extensive documentation on quality, safety, efficacy and resources are needed to demonstrate compliance, the text offers little or no room for different interpretations of the regulation. In contrast, MDD allowed diverse interpretations, which could potentially lead to errors. The spirit of MDR is to offer a streamlined regulatory process, so it also offers more training and consulting opportunities to help companies prepare. Ultimately, revision to the way medical devices were regulated was required following incidents


MDR and Brexit


When the UK left the EU on 31 January 2020, it operated and observed EU laws through a transition period that ended on 31 December 2020. From 1 January 2021, the EU and UK have operated as separate sovereign jurisdictions subject to agreements on individual matters. While the medtech industry was preparing for the ‘date of application’ of MDR with all the accommodations and adjustments made as a result of the Covid-19 pandemic, the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) were updated for the UKCA mark. This means companies with marketing interest in both the UK and EU should make preparations to comply with two separate regulatory regimes, although, until 30 June 2023, the UK will accept CE-marked medical devices if they are registered with the MHRA by the manufacturer or its UK responsible person. Under the UK MDR, UK approved bodies will operate in the same way as their EU counterparts, the notified bodies.


such as the Poly Implant Prothèse breast implant and the metal-on-metal hip implants scandals. The EU MDR provides a robust regulatory framework for ensuring that safer products that operate as intended are approved for use to improve health outcomes. The high cost is one of the key factors in attaining CE certification but quality, safety, and efficacy cannot be compromised and MDR is the right approach for ensuring this. Re-evaluating the strengths and weaknesses of the regulation itself as part of the transition process could help companies make better progress towards attaining or maintaining CE certification. ●


Medical Device Developments / www.nsmedicaldevices.com


23


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120  |  Page 121  |  Page 122  |  Page 123  |  Page 124  |  Page 125  |  Page 126  |  Page 127  |  Page 128  |  Page 129  |  Page 130  |  Page 131  |  Page 132  |  Page 133