A Delay to the MDR? | Joe Hagan-Brown

On 6th January 2023 the European Commission published a press release concerning a new proposal- 2023/0005. The proposal aims to ease the bottleneck issues and avert catastrophic unavailability of medical devices in Europe due to a lack of Notified Body certificates being issued for the Medical Device Regulation 2017/745 (MDR) regulatory framework. The proposal should it be adopted by the European Parliament, will see the new regulation be subject to a more gradual introduction- for up to 5 years for low to mid risk Class I, IIa and IIb non-implantable medical devices (2028), and up to 4 years for high-risk class III and IIb implantable devices (2027). There has been a growing level of concern amongst all sides of our industry as to the feasibility of the timescales for implementation of the medical device regulations ever since the proposal for a new regulation to replace the now obsolete Medical Device Directive was first proposed.

Be under no illusion though- the MDR is not being postponed or annulled, but rather amended. It still applies and it is only under the revised transitional provisions which the proposal sets out that devices previously certified under the Medical Devices Directive 93/42/EEC (as amended) (hereafter the MDD) may continue to be marketed. Furthermore, article 1 of the proposal sets out that Article 59 and article 97 derogation processes, as they currently exist within the MDR, will be a fundamental enabler of the process for allowing MDD certificates to be resurrected or live on. The MDR is not being postponed. Rather the run way for take off has been extended a little.

Manufacturers looking to benefit from this extended run way will also need to meet a number of stringent conditions, set out in article 1 of the proposal, including having made an application to a Notified Body for MDR certification, and an article 59 or article 97 permission, having been granted by the competent authority.

There can have been no significant design changes to the device in question. There must also be evidence that the device does not present an unacceptable risk to the heath or safety of patients user or other persons or to other aspects of the protection of public health.

The new timescales proposed will be welcomed by many businesses who have been unable to sell devices due to MDD certification having expired prior to MDR certificates having been issued. Many questions remain as to the exact mechanisms which will be employed to enable the proposal practically should it be adopted. The proposal now needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.

It must be acknowledged that the MDR introduces a complex set of regulatory requirements when compared to the MDD. To illustrate this relative complexity, we can look at the guidance produced to support each to date. The Medical Devices Directive 93/42/EEC (as amended) was the main legislation governing medical devices in Europe for 20 years until its replacement by the MDR (EU)2017/745. In 20 years, the MDD was supplemented by a number of guidance documents known as MEDDEVs. These commission endorsed guidance documents covered a range of topics such as classification, clinical evaluation, post market surveillance, vigilance reporting amongst other. The aim of the documents was to encourage a more uniform approach to the interpretation of the Directive. In total 26 MEDDEVs were produced in relation to the common interpretation of directive 93/42/EEC over the 22-year lifespan of the directive.

After the introduction of the MDR, much needed guidance was produced in the form of MDCG guidance documents, in the 5 years the MDR (EU) 2017/745 has been in existence- one fifth of the total duration of MDD applicability, over 70 MDCG Guidance documents have been published by the Medical Device Coordination Group, in a bid to encourage a more uniform interpretation of the MDR. It Is worth considering that a key aim of the introduction of the MDR to replace the MDD was to encourage a more transparent regulatory approach with a uniform interpretation of the requirements across different national territories. Such is the scale and breadth of the MDR project that such guidance is indeed very much necessary.

It is evident that the implementation of the MDR has been a challenge not only for manufacturers, but for the entire industry. economic operators, notified bodies, competent authorities alike are all grappling with the regulatory burden the new regulations bring. Proposal 2023/0005 is aimed at helping ease the burden for all parties. It remains to be seen if the proposal, once adopted will have the desired outcome.