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Regulatory Trends in Medical Devices

Aug 02, 2023 Regulatory Trends in Medical Devices

A 12-18 Month Outlook

A 12-18 month outlook for regulatory trends in Medical devices

Medical Devices continue to witness growth in regulations with recent developments such as the overhaul of the medical device regime in the EU, advancements in artificial intelligence and concerns about cybersecurity.

These changes, in tandem with concerns regarding restriction of chemicals substances in products and other regulations pertinent to electronics, in general, mean that manufacturers of medical devices need to continuously monitor and assess regulatory requirements to ensure compliance.

Figure 1 shows this growth has reached unprecedented levels with a 64% increase in Regulations for medical device manufacturers since 2015 with 13,485 Regulations in place by 2022. 

Global Regulatory Trends for Medical Devices

(Source: C2P by Compliance & Risks)

Key Areas of Concern & Hot Topics

Here’s a bird’s-eye view of key regulatory trends and issues you need to be aware of to get your product on the market and keep it there:

Regulatory Density for Medical Device Manufacturers globally - Source C2P by Compliance & Risks

(Source: C2P by Compliance & Risks)

Top Trending Regulations

Listed below are the key regulations that will be impacting your business over the next 12-18 months:

  • EU: Medical Devices, Regulation (EU) 2017/745 and Others – Amendment – (on transitional provisions for certain medical devices and in vitro diagnostic medical devices) Regulation (EU) 2023/607
  • EU: Q&A on Practical Aspects Related to the Implementation of Regulation (EU) 2023/607, Guidance Document, Revised, July 2023
  • EU: Common Specifications for Certain Products without Intended Medical Purpose listed under Medical Devices Regulation (EU) 2017/745, Regulation (EU) 2022/2346 – Amendment – (on transitional provisions for certain products without an intended medical purpose) Regulation (EU) 2023/1194, June 2023
  • EU: Harmonised Standards for In Vitro Diagnostic Medical Devices Drafted in Support of Regulation (EU) 2017/746, Decision (EU) 2021/1195 – Amendment – (on harmonised standard for sterilization of medical devices) Decision No. 2023/1411, July 2023
  • EU: Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Regulation (EC) 1907/2006 – Proposed Amendment – (on postponing in Annex XIV the latest application and sunset dates for uses of DEHP in medical devices) Draft Regulation, May 2023
  • Australia: Transition to New Manufacturer Evidence for IVD Medical Devices, Guidance Document, June 2023
  • Australia: EU MDR Transition, Guidance Document, May 2023
  • IMDRF: Principles and Practices for the Cybersecurity of Legacy Medical Devices, Guidance Document, April 2023
  • UK: Medical Devices Regulations, SI 2002/618 – Amendment – (on extending the periods during which manufacturers can place CE-marked medical devices on the GB market, etc) Regulations, SI 2023/627
  • Japan: Guidance on Approval and Development of Software as a Medical Device (SaMD), Guideline, March 2023
  • Malaysia: Transition Period for the Implementation of Electronic Medical Device Registration Certificate, Announcement, 2023
  • USA: Content of Premarket Submissions for Device Software Functions, Guidance Document, June 2023
  • South Korea: Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices

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