Medical Device Regulations Changes coming with Brexit.

Listen to this highlight from RCA Radio where Seyed Khorashahi breaks down the UK’s Medical Device Regulations resulting from Brexit and choosing not to join the EU MDR.

 

 

Listen to the entire episode where we go over Brexit and all of the important things happening in the Medical Device industry here.

---

Looking for help adhering to the New Brexit Regulations? Contact Us Now →

---

Changes with Brexit

The UK will not be transitioning to the EU MDR or IVDR and will be staying with MDD, AIMD, and IVDD. They plan on making changes in the future as necessary for the UK market.

 

CE Marking

The MHRA will recognize the CE Mark for devices until June 30^th, 2023. This applies to products CE marked under the

• MDD, IVDD, AIMDD, and as well as MDR and IVDR.
• Class I and General IVD manufacturers can continue to self declare.

 

Conformity Assessment Marking (UK CA)

• UK Notified Bodies will become UK approved bodies starting January 1^st, 2021
• Device Manufactures can use UK approved bodies for UK CA marking starting on January 1^st, 2021
• UK CA marking will be mandatory on July 1^st, 2023

 

MHRA Registration Requirement Dates

 

• May 1^st, 2021
  • Class III medical devices & IVD list A devices
  • Class II b implantable devices
• September 1^st, 2021
  • Class II b non-implantable and II a & IVD list b products
• September 1^st, 2022
  • Class I medical devices and general IVDs

 

UK Responsible Person

Manufactures without a presence in the UK will need a UK responsible person which can be an individual or company similar to EU authorized representative.

 

About RCA^®

 

Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science challenges:

 

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA, and globally regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

About Sotera Health^®

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance Associates^® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.