- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (27/07/2021)
- Gwreiddiol (a wnaed Fel)
There are currently no known outstanding effects for the The Medical Devices (Northern Ireland Protocol) Regulations 2021.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
PART 2 Making available on the market and putting into service under Regulation (EU) 2017/745
PART 3 Clinical investigations under Regulation (EU) 2017/745
12.Prior authorisation of clinical investigations by the Secretary of State
13.Arbitration following the refusal of a clinical investigation application
14.Damage compensation in relation to clinical investigations
15.Retention of documentation relating to clinical investigations
17.Clinical investigations not carried out for a purpose specified in Article 62(1)
PART 4 Notified bodies designated under Regulation (EU) 2017/745
PART 5 General provision about language requirements and fees
PART 8 Amendment of the Medical Devices Regulations 2002
31.Amendment of regulation 2A (medical devices which are qualifying Northern Ireland goods)
33.Amendment of regulation 10A (UK(NI) indication: general medical devices)
34.Amendment of regulation 19 (registration of persons placing general medical devices on the market)
35.Amendment of regulation 21B (registration of persons placing active implantable medical devices on the market)
36.Amendment of regulation 24A (UK(NI) indication: active implantable medical devices)
37.Amendment of regulation 36A (UK(NI) indication: in vitro diagnostic medical devices)
PART 9 Amendments of other secondary legislation
38.Amendment of the Blood Safety and Quality Regulations 2005
39.Amendment of the Human Tissue (Quality and Safety for Human Application) Regulations 2007
40.Amendment of the Legislative and Regulatory Reform (Regulatory Functions) Order 2007
41.Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
42.Amendment of the Economic Growth (Regulatory Functions) Order 2017
43.Amendment of the Market Surveillance (Northern Ireland) Regulations 2021
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.
Pwynt Penodol mewn Amser: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Mae Memoranda Esboniadol yn nodi datganiad byr o ddiben Offeryn Statudol ac yn rhoi gwybodaeth am ei amcan polisi a goblygiadau polisi. Maent yn ceisio gwneud yr Offeryn Statudol yn hygyrch i ddarllenwyr nad oes ganddynt gymhwyster cyfreithiol, ac maent yn cyd-fynd ag unrhyw Offeryn Statudol neu Offeryn Statudol Drafft a gyflwynwyd ger bron y Senedd o Fehefin 2004 ymlaen.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys