Articles from the Archive – In Case You Missed It
Our expert team has written over 300 insightful articles on all aspects of regulatory affairs. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this third edition of #ICYMI (In Case You Missed It) we are featuring articles on issues as diverse as how social media can impact on PV, Brexit, the impact of the EU MDR on economic operators and more.
Good Pharmacovigilance Practice (GVP) at its core aims to prevent harm from adverse reactions in humans from medicines and to promote the safe and effective use of medicinal products. Pharmacovigilance professionals are aware that adverse reactions can be reported from a variety of sources – patients, healthcare professionals, competent authorities or marketing authorisation holders. Robust pharmacovigilance however depends greatly on complete and timely reporting of adverse reactions. And herein lies the problem – it is estimated that over 90% of adverse drug reactions are under-reported. Read the article here.
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2021 and the IVDR in May 2022. Note: (This page was updated in April 2020 to reflect the changes to the MDR implementation date)
Now is the time for those impacted by the changes to the medical devices regulatory landscape to prepare for implementation of the new regulations. In this, the first of a number of articles relating to EUDR, we look at some of the changes for Economic Operators.
In the current Directives, the legal responsibility for medical devices placed on the market lies firmly with the legal manufacturer of the device. The role of Authorised Representative for manufacturers based outside of Europe was established in the Directives but under EUDR the increased responsibilities of this role are more clearly defined. The new regulations specify obligations and responsibilities for all economic operators involved in the manufacture and supply of medical devices. Read more here.
Does your company currently have an EU Authorised Representative that is based in the United Kingdom? If so, your company will have to consider changing EU Authorised Representative soon to ensure that you have representation with the European Union once the UK leaves the European Union.
The UK’s impending departure from the EU will necessitate a change in designated EU Authorised Representatives for companies that are currently using a UK based authorised representative at present. This will cause considerable upheaval and disruption to companies using such a service. The consensus view that Britain will seek to leave using a hard Brexit mechanism means that there is scant hope of companies being able to maintain representation through UK representatives. Read more here.
SO 9001:2015 Quality Management Systems – Requirements was published in September 2015 with a three-year transitional period. For organisations that have not yet upgraded to the revised standard, the ISO 9001:2008 certification expiry date will soon be approaching. Control of documents is an intrinsic element of ISO 9001: 2015 and with the transitional period set to end you should be aware of the need to maintain and retain. We explain how you can best manage documented information in this article. Read more here.
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