On the 24 January 2019, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published contingency legislation which provides regulatory guidance for medicines, medical devices and clinical trials in the event that the UK departs the EU with no agreement on 29 March 2019. The Secretary of State, Stephen Hammond, also signed off on the UK government’s “Impact Assessment” on 22 January 2019, found here, which discusses information regarding the approach of the UK government to legislation. (Important Note: These regulations are subject to approval by Parliament and are yet to be voted on.)
While there remains hope that a ‘no deal’ scenario does not occur, with ongoing negotiation both within the UK government and the EU, the UK Parliament continues to prepare for the worst case scenario; EU medical device manufacturers must also consider this potential eventuality.
The extensive legal text within the MHRA contingency legislation makes the document challenging to understand in comparison to the Medical Device Regulation (MDR), but the key messages for EU manufacturers are as follows:
- The UK draft legislation contains provisions for the Medical Device Directive (MDD), Active Implantable Medical Device (AIMD) and InVitro Diagnostic (IVD) legislation in a single document. It does not directly replicate the MDR 2017/745 and IVDR 2017/746 however, the transition timelines of these regulations remain the same.
- As expected, the UK intends to mirror the benefits of the revision of the existing MDD, AIMD and IVD legislation to the MDR and IVDR, with the draft legislation containing similar requirements and no major technical deviations.
- The structure of the UK legislation is similar to the EU legislation, with EU Articles replaced with item numbering and Annexes replaced with “Schedules.”
- CE Marking remains the route to access the UK market, with the requirement for non-UK manufacturers to have a “UK Responsible Person” (item 77 in the UK document), analogous to the EU Authorised Representative described in Article 11 of the MDR.
- The “UK Responsible Person” should not be confused with the requirement for Economic Operators to have a “Person Responsible for Regulatory Compliance (PRRC), described in item 80 (analogous to Article 15 of the MDR).
- The scope and definitions remain unchanged but helpfully, definitions are now presented in alphabetical order to facilitate easier reading and reference.
- Harmonised Standards are replaced with “Designated Standards.”
- The UK Secretary of State takes the responsibilities covered by the EU Commission; there is no analogous body to the Medical Device Coordination Group (MDCG) or expert panel review.
- Although Notified Bodies (NB) are mentioned, there is no equivalent schedule to Annex VII of the MDR (requirements to be met by NBs)—it is unlikely that the current model will be changed, but perhaps this is the case to allow for further considerations regarding how the conformity assessment process will be addressed in the future.
Although it is important for manufacturers to consider how they will access the UK market after the official date of Brexit of 29 March 2019, there remains a strong drive in the UK to avoid the ‘no deal’ scenario, so the likelihood of needing to utilize this legislation remains uncertain. It is therefore recommended that manufacturers based in either the EU or third countries outside of the EU take this legislation into consideration as part of contingency planning should the worst case scenario occur.
At this time, NAMSA is not aware of any organizations within the UK that offer specific “UK Responsible Person” services, but it is expected that the established EU Authorised Representatives in the UK will rapidly set up this service offering.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. Additionally, NAMSA’s Regulatory Team is enriched with experts from five leading Notified Bodies that have a deep-rooted understanding of EU submissions, proven to save medical device organizations up to $17M in costs and 23 months in development timelines.
If you would like to discuss the impact of these recent EU regulatory changes, please get in touch with us by visiting https://www.namsa.com/contact-us/ or by calling us directly at +1-419-666-9455.
Adrian Keene
Adrian is Director of EMEA Consulting Services at NAMSA where he utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products. Adrian previously Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In all, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.