19 Jul 23
On 7 March 2023, the Council of the European Union (EU) voted to adopt the Commission’s proposal to extend the Medical Device Regulation 2017/745 (MDR) transition period, and the proposal was formally adopted on 15 March 2023 by the European Parliament and the Council. The Official Journal has now been published and the MDR extension has entered into force as of 20 March 2023. Providing certain conditions have been met, manufacturers now have until 2027 or 2028 to achieve MDR certification, depending on the classification of the device.(1)
At the time of writing there are 38 notified bodies designated for the MDR, whereas approximately 96 notified bodies were designated for the Medical Devices Directive MDD/93/42/EC (MDD). This reduction in notified bodies has had a significant impact on the capacity for performing conformity assessments. This reduced capacity, along with manufacturers being insufficiently prepared for MDR assessment, has been the driving force behind the MDR extension. This reduced capacity is evident in Figure 1, there is a large disparity between the amount of applications received under the MDR versus the amount of certificates issued under the MDR.
The extension gives manufacturers until 2027/2028 to achieve MDR certification by not only extending the transition period but also the validity of certificates issued under the MDD. However, this does not mean that the MDR in its entirety is postponed; the MDR has been applicable since 26 May 2021, the date of implementation. The extension is limited to amending the transitional provisions only allowing manufacturers and notified bodies additional time to transition subject to conditions;(3) the MDR requirements not covered by the transitional provisions should already be in place. The extension timeline allows for MDD‑certified Class III and Class IIb implantable devices to be placed on the market until 31 December 2027, with Class IIb (non implantable), IIa and I devices (which now require notified body involvement and have a Declaration of Conformity signed prior to 26 May 2021) to be placed on the market by 31 December 2028.(4) To benefit from this extension all the following conditions must be met:(1)
Although the extension dates allow manufacturers more time to achieve MDR certification, it is clear from the conditions that work on compliance must continue. There is still a lot of work to be completed by May 2024 to benefit from the extension, if the manufacturer has not yet implemented a QMS compliant to the MDR or started discussions with notified bodies for assessment.
The minimum requirements for a QMS, according to Article 10(9) of the MDR and the corresponding International Organization for Standardization (ISO) 13485 clauses which meet each requirement, are shown in Figure 2. Having a QMS is a requirement of the MDR and the only QMS standard referenced on the EU list of harmonised standards(5) is European Standard (EN) ISO 13485. Therefore, most companies utilise EN ISO 13485:2016 to show compliance to the MDR although use of the standard itself is not mandatory.
Additional MDR requirements, not previously covered by the MDD, include the use of unique device identifiers (UDIs) which is covered in Article 27 of the MDR.(6) The UDI, which is a series of numeric and alphanumeric characters, is intended to enhance device traceability, competent authority monitoring and reduce the number of falsified devices.(7) The primary identifier of the device model is the basic UDI-DI (the DI suffix referring to the device identifier), which is the main component for device-related information in the European Database on Medical Devices (another new requirement from the MDR); the intent of the basic UDI-DI is to identify devices with the same intended purpose, risk class, and essential design/risk management characteristics. The QMS, and technical documentation, must address the application and use of UDIs and the UDI must be present on the device itself.(6)
Further clinical information may be required for some devices under the MDR. The Summary of Safety and Clinical Performance (SSCP) is a new requirement in the MDR for manufacturers, which dependent on the classification of the device may need validation by the notified body. The SSCP should be implemented within the QMS of the manufacturer, ideally using the template in the Medical Device Coordination Group guidance document MDCG 2019-9.(8) Additional post-market surveillance (PMS) requirements are also included in the MDR, which build on those present in the MDD such as periodic safety update reports (PSUR). Hence, it is essential that manufacturers ensure their QMS covers all applicable additional clinical and PMS requirements.
Another new addition to the MDR is the strategy for regulatory compliance, which is an essential part of the conformity assessment process. Article 10 of the MDR and Annex IX on conformity assessment references this strategy: it must be documented, implemented, and maintained as part of the QMS. The strategy for regulatory compliance may also be used to address the requirements for the person responsible for regulatory compliance (PRRC).(9) The PRRC is a new addition for manufacturers, and the PRRC is responsible for checking the conformity of the device prior to release, ensuring that regulatory documentation is maintained, and that PMS obligations are met, among others. These responsibilities may be split between multiple people and must be integrated in the QMS.(10) Manufacturers should also be aware of the following requirements that will impact the QMS: general safety and performance requirements (GSPR) which replace essential requirements (ER); additional requirements to be included on Declarations of Conformity; and terminology changes, for example reportable events are now serious incidents.
Many manufacturers who began their transition process before the MDR extension was approved may already have an updated QMS in place. For these manufacturers the extension provides a great opportunity to improve on these processes prior to evaluation by a notified body.
The changes to the MDR transition period were applied automatically in Northern Ireland under the Northern Ireland Protocol. The United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has since announced, on the 28 March 2023, that valid Conformité Européene (CE) certificates that have been extended under the EU MDR regulations will be accepted within the UK.(11) The UK government has put in place legislation (in Spring 2023), which will allow CE-marked devices to be placed on the UK market until 30 June 2030 depending on classification.(12)
In conclusion, this is not a time for manufacturers to slow down or stall their MDR application. Many requirements have been in place since the date of implementation on 26 May 2021, including:
Not only is this the perfect time to enhance existing processes in these areas to strengthen an MDR application, but it is also essential that manufacturers ensure they meet the required conditions to benefit from the MDR extension.
The tranScrip Regulatory Affairs Medical Technology team, profiled below, are able to act as PRRC and can provide support in multiple areas, including but not limited to: MDR applications, technical file updates, enhancing PMS, and creating PSURs. Whilst the MDR extension is good news, it is critical that manufacturers continue to strive for MDR compliance. If you require any advice or support on how to manage this transition, please contact us via our website: https://www.transcrip-group.com/contact-us/
Trisha has worked in regulatory affairs since 2008 and has 14 years’ experience in regulatory affairs, specifically in the medical device industry. She has worked for numerous medical device manufacturers both in Europe and the United States (US), covering a vast array of medical devices portfolios, from breast implants, obesity products, wound care, acute care, patient care to orthopaedic products. During her previous employment, Trisha initiated the MDD and MDR transition project for 13 families of Class IIa and Class IIb products, in addition to successfully transitioning over 25 class I product families under MDR. In addition, Trisha was highly involved in the submission of 3 technical files to a notified body, which are currently under notified body review.
Catherine has worked in the medical device field in both quality assurance and regulatory affairs for over 30 years, working for companies manufacturing medical devices in Europe, US and Asia. Her experience includes orthopaedic implants, first aid, wound care, consumer healthcare and aesthetic devices, and CE marking Class I to Class III devices with completion of regulatory submissions and approvals in many international markets. In 2017, Catherine began an MDR project with her previous employer for 3 families of Class III implantable devices. She was instrumental within the project teams, and became the lead in planning, advising, and guiding all teams across the business to be MDR ready, followed by preparing and submitting the technical files. Catherine was also heavily involved in the lobbying of competent authorities and the EU Commission for devices falling under MDR Annex XVI. Since then, she has worked with clients preparing them for their MDR transition.
Laura has worked in regulatory affairs since 2015 and has 7 years’ experience in regulatory affairs, specifically in the medical device industry. She has worked for an orthopaedic medical device manufacturer (with products sold globally) covering QMS, clinical evaluations, PMS, Medical Device Single Audit Program, and CE marking of medical devices, from Class I through to Class IIb implantable devices. Laura began an MDR transition project with her previous employer in 2017 covering Class I and Class IIa devices and saw the company through to their QMS MDR audit in 2022. She has also advised clients on required QMS updates for MDR. As well as undertaking comprehensive training upon issuance of the regulations, her knowledge has been kept up to date due to her experience working within a manufacturer and continued development since joining tranScrip Ireland. Laura is also a qualified lead auditor for ISO 13485 – quality management systems for medical devices.
Niamh joined tranScrip Ireland, formerly Real Regulatory, in 2016 having spent 15 years working in quality compliance in the medical device sector, initially as a quality control (QC) Supervisor before being promoted to QC Manager. Niamh also worked in the pharmaceutical sector from 1990-2000 in both research and development (method development) and as a QC Chemist in a bulk pharmaceutical manufacturer. Niamh is an experienced Lead Auditor having performed supplier audits across many different disciplines within the medical device field such as sterilisation, fill/packing operations, chemical manufacturing, packaging, raw materials, and distribution. Niamh is extremely experienced with QMS and acts as PRRC on behalf of tranScrip clients.
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