Report on the Training Session on the New Medical Devices Regulation – On 4 April, the GTF Technical Committee organised a conference on the most important aspects of the new Medical Devices Regulation 745/2017, which will apply throughout the EU from the date it comes into force in 2020.
In view of the imminent entry into force of a new regulatory framework at European Union level, which will affect the legislation governing medical devices and IVDs, we at GTF M. Camps, we decided to bring together a group of technical experts from certification bodies to gain first-hand insight into what these changes will mean in practice.
Following the receipt and delivery of the materials, the Conference on the new Medical Devices Regulation -the name we gave to this Masterclass on regulation- were presented by the Director of the Pharmaceutical Technical Office, Mercè Camps, who outlined the new Regulation and the challenges it poses for regulatory affairs professionals in ensuring compliance
The Journey Begins: the new Medical Devices Regulation 745/2017
Next, Mercé Camps introduced Mª Carmen Abad, former Head of the Medical Devices Department at the AEMPS – and one of the country’s leading experts on the regulation of these products – outlined the key aspects of the new Medical Devices Regulation to the audience of nearly 50 people.
And then Carlos González , a technician at GTF M, Camps, went on to provide a practical explanation of the full contents of a Technical File to be submitted to the Notified Body, in accordance with Annex II of the Regulation.
Following his presentation, the students – a technically-minded audience comprising industry professionals: managing directors, technical directors, lead engineers and representatives from regulatory departments – were able to take a short break, have a coffee and chat briefly with the speakers. And after the break, it was back to business.
Things are getting more complicated: Updates to ISO 13485:2016 and regulations on electrical and electromagnetic equipment
The first presentation in the second session was on the changes in the new version of ISO 13485:2016, and was given by Isabel Lopez Warrior, from EpisKey Medical Consulting, S.L. And the second, from Jesus Antonio Diaz, from Cetemed, a laboratory that forms part of CERE and offers, to products that meet the relevant standards, UNE-EN ISO/IEC 17065:2012 and UNE-EN ISO/IEC 17025:2017 certifications. Diaz spoke to us about the tests to be carried out on medical devices to ensure compliance with regulations governing electrical and electromagnetic equipment.
After these two lessons on various aspects of the new Medical Devices Regulation, we stopped for lunch and had a chat for a while in a more relaxed atmosphere. And after coffee, we went back to class.
The new Medical Devices Regulation: Legal aspects, relations with Notified Bodies, validation of software and apps, and clinical research
The first to speak that afternoon was Gemma Colomer, from Fieldfisher Jausas, who outlined the legal aspects of the new Medical Devices Regulation. And the second slot went to Joaquim Gomez, from Kiwa, who spoke about how Notified Bodies operate and about the current timelines and requirements in the sector. And then it was the turn of Rafael Beaus y Ricardo Klein, from Azbil Telstar Technologies, who explained how new technologies are affecting the sector and discussed the requirements for the validation of medical software and apps.
Ramon López, from the M. Camps Pharmaceutical Technical Office, whose session had been scheduled for the morning but was missed due to a flight cancellation. Consequently, his presentation was moved to the end of the programme. López spoke to us about the conduct of clinical research, evaluation reports and post-marketing reports – one of the new requirements of the Medical Devices Regulation. And following his presentation, Mercè Camps We brought the day to a close and thanked those present for taking part.
For those students who attended the entire seminar on the Medical Devices Regulation, the Pharmaceutical Technical Office has issued a Diploma a course completion certificate, stating the student’s name, the name and subject of the course, and the number of hours completed.
Feedback from the organisers of the training course on the new Medical Devices Regulation (and some advice)
We would like to emphasise that, at GTF M. Camps, vWe are delighted with the warm reception these conferences have received, despite its highly technical nature. We believe that the success of this training course on the new Medical Devices Regulation is not solely down to us (nor to the renowned experts who helped us organise the course). Rather, it is down to the a strong commitment to training on the part of the sector, which is currently expanding rapidly and facing new regulatory challenges.
And we encourage both the participants and any technical staff who happen to read this to follow the training programmes that, very soon, the Technical Pharmaceutical Office and its director, Mercè Camps, which we plan to organise throughout 2019. Please note: we have extensive experience in handling regulatory affairs procedures relating to medical devices.
Do you have any questions? Our team of technicians will help you find the best solution to meet your needs.