MDR Certification

We are delighted to announce that Pennine Healthcare have been awarded our MDR Certification for Class I Sterile, Class IIa and Procedure Packs, as well as our UKCA.

This is an incredible achievement, and one which we have worked tirelessly towards, and we want to send a big thank you to all staff who played their part in making this happen.

To coincide we the announcement, we caught up with our Head of Regulatory Affairs, Arun Mahendran, to get a background into MDR and the sheer amount of work the company have undertaken to receive the certification. Over to Arun…

Before I get into the MDR activities, I would like to give some background information on this topic. The Medical Devices were regulated by the EU Directives and were introduced in 1990s. The three Directives are;

• Medical Device Directive – 93/42/EEC (most devices fall under this category)
• In-vitro Device Directive – 98/79/EC
• Active Implantable Device Directive – 90/385/EEC

The new Medical Device Regulations 2017/745 was published in May 2017, and this replaces the Medical Device Directive and Active Implantable Directive. The new MDR is significantly more comprehensive and detailed compared to the MDD. The MDD comprises 23 articles and 12 annexes over 60 pages, the new MDR has 123 articles and 17 annexes over 175 pages. The new MDR is focussed on additional safety and performance requirements compared to the MDD. Importance was given to the clinical data and stringent post-market requirements.

When I started at Pennine in August 2020, the business was still going through the MDD related activities. I saw the importance for us to transition to the new MDR.

We had to create Design History Files for all product ranges. This process was very complex and involved various stages to complete. The main challenge was to identify relevant verification and validation activities and addressing them within the scheduled audit dates. Some of the verifications/validation activities were dependant on external test laboratories, therefore we had to plan on which one to focus first. We were all working under pressure to get them on time.

The new MDR also had impact on several other documentations such as risk management (hazard analysis, usability, risk analysis), clinical evaluations, biocompatibility report, shelf-life test, transit tests, post-market reports, labelling and IFU updates. We have created and filed 7 Technical Documentations and all these requirements were built from scratch to meet the new regulatory requirement.

Usually, these documentations take a lot of time (at least 3 years). I am proud to inform that we have accomplished this within a record time of 18 months. We managed to create and submit the Technical Documentation ahead of time. This involved lot of hard work, just as an indicator, our Technical Documentations are roughly around 3000 pages long.

There were two stages in the MDR certification process;

1. MDR QMS. This audit was conducted in March 2022. Both Regulatory and Quality teams have done a wonderful job. There were no major gaps/findings during the audit.
2. Technical Documentation review: Our Oxygen tubing and Surgical Suction devices Technical Documentation were reviewed by BSI. The review was very thorough and intense, and we closed all review questions in our Round 1 process. Usually, it takes multiple rounds of questions to close the technical reviews, which again is a very good outcome from an efficient team.

Overall, the Regulatory and Quality teams have worked very hard to achieve all these over a span of 2 years. Thanks to the whole team, especially Samantha and Sejal, their contributions are exceptional, and to the business as a whole, for all the support.

This is a huge milestone for Pennine and I’m really looking forward to the future.