28th June 2018- TOPRA ‘Introduction to Medical Device Regulation in Europe’ course

Between the 13th to the 15th of June, Bryanek Regulatory attended the TOPRA ‘Introduction to Medical Device Regulation in Europe’ course. Pitched as an introduction, the course still included a good deal of interesting and valuable in-depth information.  Differences between the medical device directives and the new regulation were highlighted throughout. The early talks and case studies concentrated on whether products were considered medical devices or not and whether the device would be classified as type I, II or III. An interesting example of an unusual classification was that of a Hydrocolloid dressing. While you may think this was a low risk device, the correct classification was in fact class III due to use of gelatine in its manufacture. The question of why Maggots were classed as medicinal product and not devices- a question that had puzzled me for some time was also answered.  It is due to the maggots using digestive enzymes in their primary mode of action.

On day 2, the subjects of the talks moved on to options for the conformity assessment of the device in regards to the documentation required, the General Safety and Performance Requirements/ Essential Requirements and ISO 13485. The role of notified bodies was explained along with the process for obtaining a CE mark. The increased requirements in the regulation for Clinical Evaluation and Post Marketing Clinical Follow-up, in the wake of such scandals as the metal-on-metal hip replacements, vaginal mesh and PIP breast implants, was also covered.

On the third and final day, the reporting requirements for Post Market Surveillance and Vigilance were detailed. Some of the deadlines to report events to the competent authorities are very challenging. This is especially true in this age of social media, when an event may not be received by the manufacturer through the expected channel. This could potentially cause a delay in the information reaching the correct contact within the organisation and hence delay its assessment and reporting to the Competent Authority. Following a talk on Risk Management, the final talk was on Medical Device regulation in markets outside the EU such as the USA and Japan. This was of particular interest to me as many of the US orientated Regulatory Affairs Professional Society (RAPS) forums contain a great deal of Medical Device discussions. This talk clarified the terms and the procedures used in the USA and clarified the issues being discussed in those RAPS forums.

I have not described the subject or content of all the talks in the course as it is my intention to give an overview of the highlights of the course as opposed to an exhaustive and rather long list. I found the course and its’ speakers to be interesting and engaging and certainly strengthened the Medical Device regulatory knowledge possessed by Bryanek Regulatory as a company.


29th May 2018- MHRA Blog on Baseline Submissions

In case you missed it last week, on the 21st of May the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a good blog about Baseline submissions. The blog can be found here.     

25th May 2018- UK Government's Brexit Paper

On Wednesday 23rd of May, the UK government published a paper (Link) responding to the Health and Social Care Committee’s report, following the committee’s inquiry into Brexit’s impact on medicines, medical devices and other “substances of human origin” (Link). The UK government (hereafter referred to as ‘the government’) responded to 34 of the recommendations and questions raised by the committee, with inputs from other departments and agencies including the Medicines and Healthcare products Regulatory Agency (MHRA), the Office for Life Sciences, the Intellectual Property Office and the Department for Exiting the European Union.

The concerns range from the adoption of the new clinical trials regulation, the UK’s continued participation in clinical trials, to the potential mass exodus of Qualified Persons (QPs) to the EU. A common theme of the committee’s concerns, recommendations and questions is the need for transparency especially in regards to impact assessment and contingency planning. The committee argues that instead of harming negotiations this will in fact build confidence that the UK has a ‘fall-back’ position in the event that negotiations do not result in the desired outcome.

As could probably have been anticipated, the government’s responses are largely lacking in detail. This is explained as being due to the need to “manage information carefully in order to not disadvantage the UK’s position” whilst engaged in on-going negotiations. The government’s paper does however strike a positive up-beat tone. Citing recent progress in negotiations, the government are “increasingly confident that the prospect of a “no deal” scenario is highly unlikely” and that the UK is “in a strong position from which to seek to agree a mutually beneficial way forward.” The government reiterated its commitment to a “smooth and orderly withdrawal from the EU” and “recognises the importance of a close and cooperative relationship between the UK and EU in the field of medicines regulation and science and research collaboration.”

In the event that the government are unable to establish the desired working relationship with the EU and the European Medicines Agency (EMA), the government commits to “establish a regulatory system that continues to protect the interests of patients and strengthens the UK life sciences industry.”

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