Change in the Medical Device industry | Joe Hagan-Brown

Our industry is in a critical phase of change, and increased regulatory burden on manufacturers, practically means additional costs associated with achieving regulatory compliance.

 Having access to regulatory affairs specialists with quality and regulatory experience in medical device manufacturing and conformity assessment/ Notified Body audits should form a key part of any business strategy to achieve regulatory compliance in the most cost-efficient manner. The MedRAS team is built upon the expertise of consultants who have long standing manufacturing, quality and regulatory affairs experience, including in the conduct of manufacturer, notified body, and competent authority audits, across the global medical device regulatory framework.

 UKCA marking

Further to Brexit, as of 1st Jan 2021 the rules which apply to medical device manufacturers have changed in a number of ways. The current position of the MHRA is that recognition of CE marked medical devices in lieu of UKCA markings will cease to be acceptable as of 30th June 2024.

 CE Marking

The medical devices directive (MDD 93/42/EEC) as amended, has been replaced by the EU 2017/745 Medical Device regulations which applied in full as of 26th May 2021. The new regulation introduced a more stringent set of classification rules, safety and performance requirements, and obligations to be met by medical device manufacturers, authorised representatives and distributors. Current MDD certificates issued by Notified Bodies are all set to expire within the next 2 years. From 25th May 2024, MDD 93/42/EEC CE certificates will all cease to be valid. A new CE certificate, which has been issued as per the requirements of regulation EU 2017/745 (the Medical Device Regulations) will be required in order to place medical devices onto the EU market.

 The coronavirus pandemic led to businesses including manufacturers, distributors, suppliers and even notified bodies, raising concessions on and postponing specific quality management activities over the past 2 years, in order to prioritise and redeploy resources to where they were most needed in the midst of the global covid crisis. Whilst the risks associated with coronavirus continue to exist, many business activities are returning to normal. However, after two years of postponed internal audits, supplier audits, remote and or delayed Notified Body audits, and a reduction in management oversight, how can you be sure your Quality Management System processes continue to meet the evolving regulatory requirements?

 MedRAS Readiness tool

MedRAS has developed a free, online tool which you can use to aid the identification of the state of readiness of your organisation. The Readiness tool works in any modern internet browser and you can use it to determine how ready your organisation is for the current and approaching changes to the medical device regulatory framework.

 Use the tool and download your free MedRAS Readiness results.

 Scenarios we can help with:

  • A medical device manufacturer looking to prepare for your transition from MDD 93/42/EEC to EU MDR 2017/745. We can help you identify gaps and weaknesses within your Quality management system, and then work with you to resolve these ahead of your initial notified body audit. MedRAS is on hand to guide you through the Notified Body audit process.
  •  A medical device manufacturer looking to embark on their initial MDR technical file review. Perhaps your device was class I under MDD legislation, and has been up classified to class IIa or higher due to the new more stringent classification rules which apply under MDR 2017/745. We can help you compile your new or updated technical file/documentation to ensure you are ready for MDR compliance.
  •  An ISO 13485 certified manufacturer who needs a thorough third-party audit of yours or your critical suppliers Quality management system to verify that the QMS is suitable to support the production of your key product or product portfolio. Our consultants are qualified ISO 13485 lead auditors, who have experience working as auditors for Notified Bodies, UK Approved bodies, medical device manufacturers and national and international regulatory bodies. We carry out comprehensive quality management system audits which will assess regulatory compliance with the same level of scrutiny which Notified bodies, and other regulatory authorities carry out their assessments.

 Visit our website to learn more about our services and how we can help your organisation