search.noResults

search.searching

saml.title
dataCollection.invalidEmail
note.createNoteMessage

search.noResults

search.searching

orderForm.title

orderForm.productCode
orderForm.description
orderForm.quantity
orderForm.itemPrice
orderForm.price
orderForm.totalPrice
orderForm.deliveryDetails.billingAddress
orderForm.deliveryDetails.deliveryAddress
orderForm.noItems
AlexLMX; Karloni/Shutterstock.com


Regulatory


After years of fevered speculation, and maybe even a few weeks of planning, OEMs awoke on 26 May 2021 to fi nd that the EU’s new Medical Device Regulation had become legally binding. Gabriel Adusei, associate director at Guidehouse Europe, explains how companies and regulators are adapting to the shifting environment.


he new European Medical Device Regulation (MDR) 2017/745 is perceived as one of the most extensive and robust regulations in the world. It was published in the Official Journal of the European Union on 5 May 2017 and “entered into force” 20 days later on 26 May 2017. It must be noted that ‘entering into force’ is not the same as becoming applicable. The Medical Device Directive (MDD) 93/42/EEC remained applicable through the transition to the new MDR. The date of application was also postponed from 26 May 2020 until 26 May 2021. This was seen as a ‘grace period’ for the industry as it dealt with the impacts of Covid- 19. Despite the extra time to review and prepare for MDR, there are a number of elements that have continued to pose a challenge to manufacturers.


One of the most significant changes concerns the way in which medical devices are classified. The scope of MDR has been expanded to include products that do not have an intended medical purpose but carry similar risks to medical devices. Examples of these devices are listed under Annex XVI and they include products such as fashion contact lenses, sunbeds and liposuction equipment. In addition, devices that are used for cleaning, sterilisation and disinfection, such as autoclaves and contact lens cleaning solutions, are now considered medical devices in their own right and fall under the scope of MDR.


MDR has 22 rules for classifying a medical device; an increase of four rules compared with its predecessor. These rules must be read carefully by


20 Medical Device Developments / www.nsmedicaldevices.com


A seismic shift T


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